CAPA Plan

FDA form for corrective action and preventive 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

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: 12 April 2016
Authorized by: RFO-NCR, Records Management Team

Form No. QWP-SL-RFO-1-05 Annex 1
Corrective Action and Preventive Action Plan

Rev 02
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

CORRECTIVE ACTION AND PREVENTIVE ACTION PLAN
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: 12 April 2016
Authorized by: RFO-NCR, Records Management Team

Form No. QWP-SL-RFO-1-05 Annex 1
Corrective Action and Preventive Action Plan

Rev 02
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

CORRECTIVE ACTION AND PREVENTIVE ACTION PLAN
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: 12 April 2016
Authorized by: RFO-NCR, Records Management Team

Form No. QWP-SL-RFO-1-05 Annex 1
Corrective Action and Preventive Action Plan

Rev 02
Page 3 of 3