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