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Corrective Action and Preventive Action Plan: RFO/CO
Corrective Action and Preventive Action Plan: RFO/CO
Corrective Action and Preventive Action Plan: RFO/CO
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa
II
RFO/CO: ______________________
Deficiency Description of deficiency Corrective Action /Preventive Actions Evidence of compliance Completion or Inspector(‘s) Comment(s) Response
number (CAPA) proposed completion accepted
date dd/mm/yyyy (Yes / No)
(1) (2) (3) (4) (5) (6) (7)
CRITICAL
MAJOR
OTHERS
No attendance to appropriate FDA
1.
licensing Seminar
No standard operating procedures
on a.) Pharmacovigilance
2. b.) Procurement
c.) Handling returned products
from customers
No certificate of calibration of
3.
thermometer
Date Effective: 02 July 2018 Corrective Action and Preventive Action Plan Rev 01
Form No. QWP-FROO-06 ANNEX 28 Page 1 of 2
For FDA use only:
Remarks
Date Effective: 02 July 2018 Corrective Action and Preventive Action Plan Rev 01
Form No. QWP-FROO-06 ANNEX 28 Page 2 of 2