UNIQUE PHARMACEUTICAL LABORATORIES MARKET COMPLAINT REGISTER Year 2019

Plot No: 4, Phase IV, GIDC, Panoli.

(A div. of J.B. Chemicals & Pharmaceuticals Ltd.)

Reference SOP No : QA 0118

Sr.
No. Name of Product
Complain Date of Batch No. / Type of
along with Mfg. Exp. Name & Address of complainer Complaint Details CAPA Status
No. Receipt Lot no. Complaint
Strength

1 MC/19/01 1/9/2019 Rantac Injection IRU8004 Non-Critical Feb-18 Jan-21 Ms. Alvinder Kaur A/P Surban When unpacking the injection Small blade (cutter) is part of packing material and shall be
50mg/2ml Singh, Unimed Sdn. Bhd. Ranitidine Ampoules from the placed on duplex tray with 10 ampoules and one leaflet.
pack, found out that there is a
small blade unprotected, M/S Unimed, Malaysia is requested to inform about any other
uncovered underneath one of the suitable configuration for placing the ampoule cutter in pack or Closed
ampoule. This may lead to removal of ampoule cutter from the pack.
workplace injury to the staff thus
is extremely dangerous.

2 MC/19/02 1/21/2019 Serflax Injection IIP8014, Non-Critical Aug-18 Jul-20 Elizabeth Leon, Compras The cover detaches easily. Leaflet revised for incorporation of method of cannulation.
IIP8015 Internacionales.
Av. de los Angeles 303, Bodega
3A San Martin Xochinahuac,
Azcapotzal. Closed

3 MC/19/03 2/7/2019
Macaine HCl 0.5% IDC6001 Critical May-16 Apr-19 Mediclinic Milnerton Lack of efficacy. Based on the investigation and analytical results of retained
Spinal Inj with Cnr Racecourse & Koeberg samples, it is concluded that the product batch was
Dextrose Road, 7441Milnerton manufactured using standard quality of raw materials and as per
procedure mentioned in batch manufacturing record. The
product batch is of standard quality and no any probable or
exact cause is identified related to complaint nature.

This complaint has been evaluated by our medical department Closed

and the evaluation report

4 MC/19/04 3/11/2019
Unihexol 350 I0D8022 Critical Sep-18 Aug-21 A doctor, Head of Clinical Adverse Drug Reaction Reported complaint is already mentioned in product literature
injection 100 ml Diagnostic center of the ministry and not related to Product quality. Hence, No Corrective action
of the republic of Udmurtia, 87b, and preventive action is required.
Lenina str., Izhevsk city,
Republic of Udmurtia, Russia, Closed
426009

5 MC/19/05 3/18/2019 Contrapaque 350 I0D7013 Critical AUG - 2017 JUL - 2020 Queen Edinene, Senior Allergic/Adverse Reactions Reported complaint is already mentioned in product literature
(100ml) I0L7004 APR - 2017 MAR - 2020 Radiographer, Lifebridge and not related to Product quality. Hence, No Corrective action
Lek- Pamidol 370 Diagnostic center. and preventive action is required. Closed
(100ml)

6 MC/19/06 4/23/2019 Pamidol 300mg I0K8008 Non-Critical Mar-18 Feb-22 National Pharmaceutical Product does not have UNIQUE Training has been imparted to all concerned personnel for more
Injection 50ml Regulatory Agency Hologram. vigilant during checking presence of Hologram on Carton packs
prior to packing into the inner boxes. Closed
 UNIQUE PHARMACEUTICAL LABORATORIES MARKET COMPLAINT REGISTER Year 2019
Plot No: 4, Phase IV, GIDC, Panoli.
(A div. of J.B. Chemicals & Pharmaceuticals Ltd.)

Reference SOP No : QA 0118

Sr.
No. Name of Product
Complain Date of Batch No. / Type of
along with Mfg. Exp. Name & Address of complainer Complaint Details CAPA Status
No. Receipt Lot no. Complaint
Strength

7 MC/19/07 4/23/2019
Pamidol 300mg I0K8008 Non-Critical Mar-18 Feb-22 National Pharmaceutical There is crystallization formed on As complainant observations are related to 1). Improper
Injection 50ml Regulatory Agency the vial cover after the aluminium handling of aluminium cap seal, exposing the rubber stopper to
seal is opened. There are also atmospheric air may lead to crystallization and 2). A product
traces of droplets in the inner characteristic, no specific CAPA is suggested.
surface of the vial which remains Closed
intact despite rotating the bottle.

8 MC/19/08 5/7/2019 Ifimol Injection I0A9001, Critical Jan-19 Dec-20 Ms. Angela Erika Vardavilla, During 100% Inspection, the From April 2019, we have qualified Brevetti Inspection
100ml I0A9002, Ambica International following quality non- machine (Equipment ID IV17/EP/SVP/15/171) for checking
I0A9003 Corporation, Philippines. conformance was observed. Aluminium seal crimping. From April 2019 onwards 100% vial
1. Foreign particle inside the bottle inspected on Brevetti machine for aluminum crimping. If bad
2. Unsealed sealing ring crimping observed during inspection, it is rejected by machine.
3. Damaged boxes Training shall be imparted to packing personnel for inspection
4. Damaged Hanger of carton/hanger.
During packing activity and any damage carton/hanger if Closed
observed shall be further taken up with carton/hanger
manufacturer.

9 MC/19/09 5/13/2019
Pamidol 300mg I0K8008 Critical Mar-18 Feb-22 Dr. Wan Daizyreena BT Wan Patients developed severe allergic Adverse events observed in patients are already mentioned in
Injection 50ml Jaafar, Pakar Radiologi, Hospital reaction within 10 minutes of product literature and not related to Product quality. Hence, No
Kemaman, Malaysia. administration. Symptoms include Corrective action and preventive action is required.
shortness of breath, dizziness, Closed
chest pain and lumpy throat.

10 MC/19/010 7/15/2019 Serflax Infusion IIP9004 Non-Critical Apr-19 Mar-21 Karol de la Vega Leakage of liquid after cannulation Since no any manufacturing problem or practices related to
100ml Av. de los Ángeles 303, Bodega in 4 out of 17 container manufacturing, packing or testing found out, which can lead to
3A, Bulging of container in 8 out of 17 mentioned nature of complaint, no definitive action plan or
San Martín Xochináhuac, container mitigation measures are required to be implemented.
Mexico. Collapse of container in 9 out of Closed
17 container

11 MC/19/011 7/24/2019 Ifimol Injection I0A9006 to Non-Critical Mar-19 Feb-21 Ms. Angela Erika Vardavilla, During 100% Inspection, the For Future orders,
100ml I0A9008 Ambica International following quality Once the consignment is arrived, we request customer to take
Corporation, Philippines. nonconformances photographs of product
were observed. cartons just after opening shipper as is, before taking out the
1. Damaged Shipper. product carton from shippers.
Closed
2. Damaged Cartons (boxes). These photographs once send back to us, it can help us to
review the condition of product
carton during transportation.
 UNIQUE PHARMACEUTICAL LABORATORIES MARKET COMPLAINT REGISTER Year 2019
Plot No: 4, Phase IV, GIDC, Panoli.
(A div. of J.B. Chemicals & Pharmaceuticals Ltd.)

Reference SOP No : QA 0118

Sr.
No. Name of Product
Complain Date of Batch No. / Type of
along with Mfg. Exp. Name & Address of complainer Complaint Details CAPA Status
No. Receipt Lot no. Complaint
Strength

12 MC/19/012 8/6/2019 Trazograf 76% Inj. 10Z8050 Critical Dec-18 Nov-23 State Healthcare Institution Poor contrasting of the vessels and Based on the investigation and analytical results of retained
20mL Ampoule Lipetsk City Hospital No. 4 organs. samples, it is
LIPETSK-MED concluded that the product batch was manufactured using
(SHI Lipetsk City Hospital No. 4 standard quality of raw
LIPETSK-MED) ul. materials and as per procedure mentioned in batch
Kommunisticheskaya 24, manufacturing record. The
Lipetsk, 398006 product batch is of standard quality.
Tel: +7 (4742) 73-08-79, fax +7
(4742) 73-04-32
E-mail: gblipetskmed@mail.ru
OKPO (All-Russian Classifier of
Enterprises and
Organizations) 74017105 OGRN Closed
(Primary State Registration
Number) 1054800198705
INN (Taxpayer Identification
Number): 4824032706, KPP
(Registration Reason Code):
482401001

13 MC/19/013 8/6/2019 Trazograf 76% 10Z8035, Non-Critical Oct-2018 SEP-2023 Radiology Department, N.S.N. "It is impossible to open ampoules As a corrective action we propose to change to 20m1 Glass
Injection 10Z8039, NOV-2018 OCT-2023 Blokhin Russian Oncology with knife in pack. The amber OPC (One Point
10Z8041, NOV-2018 OCT-2023 center Russia. knife is not fine. Only couple first Cut) ampoules in place of existing 20m1 glass amber plain
10Z8043, NOV-2018 OCT-2023 ampoules are cut good that ampoules in Trazograf
10Z8044 NOV-2018 OCT-2023 the knife is getting dull. Personal 76% for Russia and other CIS countries.
uses safety gloves but chips Existing and proposed both ampoules are having same material
cut hand and fall into ampoule of construction and
with solution" are USP Type I.
As per design of OPC ampoules, the breaking of ampoules is
very easy by applying Closed
little thumb pressure only. And do not require ampoule cutter
(knife) for breaking.
We sincerely request to provide necessary approval for
changing the ampoules to
20m1 Glass amber OPC (One Point Cut).
So that this type of problem can be avoided.
 UNIQUE PHARMACEUTICAL LABORATORIES MARKET COMPLAINT REGISTER Year 2019
Plot No: 4, Phase IV, GIDC, Panoli.
(A div. of J.B. Chemicals & Pharmaceuticals Ltd.)

Reference SOP No : QA 0118

Sr.
No. Name of Product
Complain Date of Batch No. / Type of
along with Mfg. Exp. Name & Address of complainer Complaint Details CAPA Status
No. Receipt Lot no. Complaint
Strength

14 MC/19/014 8/20/2019 Macaine HCl 0.5% IDC9001 Critical Feb-2019 Jan-2022 Transpharm Hemanstad, Lack of efficacy. Based on the investigation and analytical results of retained
Spinal Inj with IDC9002 Feb-2019 Jan-2022 387 Taljaard St, Hemanstad, samples, it is concluded that the product batch was
Dextrose HERMANSTAD 0082 manufactured using standard quality of raw materials and as per
procedure mentioned in batch manufacturing record. The
product batch is of standard quality and no any probable or
exact cause is identified related to complaint nature.
Closed
This complaint has been evaluated by our medical department
and the evaluation report

15 MC/19/015 8/20/2019 Serflax Infusion IIP9004 Non-Critical APR-2019 MAR-2021 Karol de la Vega Leakage of liquid after NA
100ml IIP8015 Aug-2018 July-2020 Av. de los Ángeles 303, Bodega cannulation.
3A, Closed
San Martín Xochináhuac,
Mexico.
16 MC/19/016 9/3/2019 Serflax infusion IIP9005 Non-Critical Apr-19 Mar-21 Julio Gutierrez, Coordinator De Missing Product Review of all packing activity established that missing of
100ml Compras Internacionales. product at manufacturing/packing
Av. de los Angeles 303, Bodega stage has not happened. Hence, CAPA is not required to Closed
3D, San Martin Xochinahuac, identify and establish.
Azcapotzalco CDMX 02120

17 MC/19/017 9/11/2019 Serflax infusion IIP9013 Non-Critical JUN-2019 MAY-2021 Julio Gutierrez, Coordinator De 14 corrugated with damaged and Review of all packing activity established that missing of Closed
100ml IIP9014 JUN-2019 MAY-2021 Compras Internacionales. 01 corrugated with double tape, 01 product at manufacturing/packing
(Paracetamol Inj Av. de los Angeles 303, Bodega piece missing (Number 12563) stage has not happened. Missing of product pack from packed
1%w/v BP) 3D, San Martin Xochinahuac, 19 corrugated with damaged and shippers is possible at depot
Azcapotzalco CDMX 02120, 02 corrugated with double tape, 2 or distribution chain. Shippers (Corrugated boxes) and cartons
Mexico. pieces missing (number: 12748 might have damaged due to
and 12802) mishandling at the time of loading and unloading during
Transportation.
Hence, CAPA is not required.

18 MC/19/018 10/2/2019 Ifimol Injection I0A9012, Non-Critical May - 2019 April - 2021 Ms. Angela Erika Vardavilla, During 100% Inspection, the Once the consignment is arrived, we request customer to take Closed
100ml I0A9015, May - 2019 April - 2021 Ambica International following quality photographs of product cartons just after opening shipper and
I0A9018 June - 2019 May - 2021 Corporation, Philippines. nonconformances before taking them out from the shippers.
were observed. These photographs can help us to review the condition of
Damaged Cartons (boxes). product carton during transportation.

19 MC/19/019 10/10/2019 Macaine HCl 0.5% IDC9002 Critical Feb-2019 Jan-2022 Mediclinic Cape Town, 21 Hof Lack of Efficacy NA Closed
Spinal Inj with Street, Oranjezicht, Mill Street
Dextrose 8010, South Africa
 UNIQUE PHARMACEUTICAL LABORATORIES MARKET COMPLAINT REGISTER Year 2019
Plot No: 4, Phase IV, GIDC, Panoli.
(A div. of J.B. Chemicals & Pharmaceuticals Ltd.)

Reference SOP No : QA 0118

Sr.
No. Name of Product
Complain Date of Batch No. / Type of
along with Mfg. Exp. Name & Address of complainer Complaint Details CAPA Status
No. Receipt Lot no. Complaint
Strength

20 MC/19/020 10/24/2019 Macaine HCl 0.5% IDC9001 Non-Critical Feb-19 Jan-22 Delta Pharmaceuticals, South During unpacking “Ampoule Review of all manufacturing and packing activity established Closed
Spinal Inj with Africa. received Damaged” that damaged to ampoules at manufacturing/packing stage has
Dextrose not happened. Ampoule might have damaged during
transportation or unloading or shifting of goods. Hence, CAPA
is not required.

21 MC/19/021 10/31/2019 Unihexol 350mg I0D8037 Critical Dec-18 Nov-22 Russian Local Hospital West- Poor contrasting of the organs. The product batch is of standard quality. So, No CAPA required
100ml Inj. Tech, Russia. as per investigation. Closed

22 MC/19/022 11/5/2019 Macaine HCl 0.5% IDC9002 Critical Feb-2019 Jan-2022 Life Vincent Pallotti Hospital, Lack of Efficacy NA Closed
Spinal Inj with Alexandra Rd, Pinelands, Cape
Dextrose Town 7405, South Africa.

23 MC/19/023 12/23/2019 Ifimol IV I0A9022 to Critical Aug-19 Jul-21 Ms. Angela Erika Vardavilla, During 100% Inspection, the Once the consignment is arrived, we request customer to take Closed
(Paracetamol I0A9025 Ambica International following quality non- photographs of product cartons just
10mg/m1) Corporation, conformances were after opening shipper as is, before taking out the product carton
Philippines. observed. from shippers.
1. Foreign Particle inside bottle These photographs send back to us, it can help us to review the
2. Faded batch Details condition of product carton during
3. Damaged boxes transportation.
4. Cracked Bottle
Category of Complaints Closing Date

2/19/2019

2/23/2019

3/21/2019

4/29/2019

5/2/2019

5/30/2019
Category of Complaints Closing Date

6/3/2019

6/23/2019

6/23/2019

8/30/2019

9/5/2019
Category of Complaints Closing Date

9/21/2019

9/19/2019
Category of Complaints Closing Date

10/3/2019

10/1/2019

10/9/2019

10/17/2019

11/11/2019

22/11/2019
Category of Complaints Closing Date

02/12/2019

14/12/2019

12/11/2019

03/01/2020
(TD - 03/02/2020)
 Other; 1; 13%

Name of System Number of Incidences SCADA; 1; 13%

E-BRM 5
SAP 1
SCADA 1
Other 1

SAP; 1; 13%
 Other; 1; 13%

SCADA; 1; 13%

E-BRM
SAP
SCADA
Other

SAP; 1; 13% E-BRM; 5; 63%

 Section Name Number of Incidences
Dispensing 0
Manufacturing 4 BSR; 1; 13%
Packing 1
RM Store 2
BSR 1

RM Store; 2; 25%

Packing; 1; 13%
BSR; 1; 13%

Dispensing
Manufacturing
Packing
Manufacturing; 4; 50%
RM Store
BSR

king; 1; 13%
 Number 5
Name of of
Person Incidenc
es Number of Incid
4.5
Bhargav
4 4
Patel
3.5

N0 Of Incidence
Mehul
1 3
Rana
2.5
Prakash
1 2
Jadhav
4
1.5
Paresh
1 1
patil
Sanjay 0.5
1
Patel 0
Bhargav Mehul Prakash Paresh San
Patel Rana Jadhav patil

1
1

0
Number of Incidences

Number of Incidences

Prakash Paresh Sanjay Pa-

Jadhav patil tel
Name Of Person
 Department Name Number of Incidences
Warehouse 3
Production 5
Quality Assurance 0

Right click to box

Format chart area
Round corners

Production; 5; 63%
 Warehouse; 3; 38%

Warehouse
Production
Quality Assurance

5; 63%
 Category of Incidence Number of Incidences

Network Communication
Error/Network connection error
1
Damage Shipper; 1; 13%

Hardware failure 0

Non-functionality of system 0

Error in the uploading of document 0

Records not retrieved from the

system
0

Backup Failure 0
Entry Error( Data
transcription/Typographical error
2

Entry missing 0
Power failure longer time 0 Others; 4; 50%
Others 4
Damage Shipper 1
age Shipper; 1; 13% Network Communication Error/Network connection error; 1; 13%

Network Communication Error/Network connection error

Hardware failure

Non-functionality of system

Error in the uploading of document

Records not retrieved from the system

Backup Failure

Entry Error( Data transcription/Typographical error

Entry missing
Entry Error( Data transcription/Typographical error; 2; 25%
Power failure longer time

Others

Damage Shipper

Others; 4; 50%