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CAPA Plan
FDA form for corrective action and preventive action plan
Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: 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:
Address:
Inspector/s:
Inspection dates:
Prepared by
:
Date prepared (dd/mm/yyyy):
(Name & Designation of establishment’s authorized representative)
Note: Establishment to fill columns 1 to 5.
Deficiency
number
(1)
Description of deficiency
(2)
Corrective Action /Preventive
Actions (CAPA)
(3)
Evidence of compliance
(4)
Completion or
proposed completion
date dd/mm/yyyy
(5)
Inspector(‘s)
Comment(s)
(6)
CRITICAL
MAJOR
OTHERS
Date Effective: 15 January 2018
Form No. QWP-FROO-06 ANNEX 28
Corrective Action and Preventive Action Plan
Rev 00
Page 1 of 3
Response
accepted
(Yes / No)
(7)
Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa
Deficiency
number
(1)
Description of deficiency
(2)
Corrective Action /Preventive
Actions (CAPA)
(3)
Evidence of compliance
(4)
Completion or
proposed completion
date dd/mm/yyyy
(5)
Inspector(‘s)
Comment(s)
(6)
For FDA use only:
Remarks
Date Effective: 15 January 2018
Form No. QWP-FROO-06 ANNEX 28
Corrective Action and Preventive Action Plan
Rev 00
Page 2 of 3
Response
accepted
(Yes / No)
(7)
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:
Date Effective: 15 January 2018
Form No. QWP-FROO-06 ANNEX 28
Name and Signature Team Leader/Supervisor
Corrective Action and Preventive Action Plan
Rev 00
Page 3 of 3