Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

RFO/CO:_____________________

CORRECTIVE ACTION AND PREVENTIVE ACTION PLAN

Name of Establishment: MJ’s Pharmacy Address: Sison, Pangasinan

Inspector/s: FDA Inspector Inspection dates: 10/28/2021

Prepared by : Majesty Ann J. Ymana - Owner Date prepared (dd/mm/yyyy): 14/11/2021

(Name & Designation of establishment’s authorized representative)

Note: Establishment to fill columns 1 to 5.

Completion or Response
Deficiency Corrective Action /Preventive Inspector(‘s)
Description of deficiency Evidence of compliance proposed completion accepted
number Actions (CAPA) Comment(s)
(2) (4) date dd/mm/yyyy (Yes / No)
(1) (3) (5) (6)
(7)
CRITICAL

N/A N/A N/A N/A N/A N/A

MAJOR

CA: Have a backup pharmacist.

1 Pharmacist is absent Hired a replacement 11/20/2021
PA: Always have a replacement.
Licensed to Operate not
1 CA: Renew the LTO immediately. See Attached file 11/20/2021
renewed
Selling Antibiotic without Requires prescription to
CA: Never sell antibiotic again Immediately after
1 Prescription patients when buying
without prescription. the inspection
antibiotics

OTHERS

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 ANNEX 28
Corrective Action and Preventive Action Plan Page 1 of 3
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

Completion or Response
Deficiency Corrective Action /Preventive Inspector(‘s)
Description of deficiency Evidence of compliance proposed completion accepted
number Actions (CAPA) Comment(s)
(2) (4) date dd/mm/yyyy (Yes / No)
(1) (3) (5) (6)
(7)
CA: Replace the ceiling fan with
Pharmacy temperature
air conditioner. Waiting for the delivery of
1 during the time of inspection 11/18/2021
PA: Ensure proper ventilation to the air conditioner.
is 35C
maintaing the quality of products
Hygrometer - Expired CA: Renew the Calibration
1 See attached file 11/20/2021
Calibration Certificate certificate
CA: Provide pallets for the stock Waiting for the pallets to
1 Stock room has no pallets 11/18/2021
room. arrive

For FDA use only:

Remarks

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 ANNEX 28
Corrective Action and Preventive Action Plan Page 2 of 3
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

Recommendation(to FDA office):

Reviewed by: Name /Designation and Signature of FDRO(s) Date:

Date:
Noted by: Name and Signature Team Leader/Supervisor

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 ANNEX 28
Corrective Action and Preventive Action Plan Page 3 of 3