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QWP-FROO-06 Annex 28 CAPA Plan Rev 01

The document is a Corrective Action and Preventive Action Plan (CAPA) form from the Republic of the Philippines Department of Health Food and Drug Administration. It contains sections for establishments to describe deficiencies found during an inspection, the corrective actions taken to address each deficiency, evidence of compliance, proposed completion dates, and space for inspector comments and approval. The form is used to document an establishment's plan to remedy issues and prevent their recurrence to achieve compliance with regulations.

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Buddy Kertun
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215 views3 pages

QWP-FROO-06 Annex 28 CAPA Plan Rev 01

The document is a Corrective Action and Preventive Action Plan (CAPA) form from the Republic of the Philippines Department of Health Food and Drug Administration. It contains sections for establishments to describe deficiencies found during an inspection, the corrective actions taken to address each deficiency, evidence of compliance, proposed completion dates, and space for inspector comments and approval. The form is used to document an establishment's plan to remedy issues and prevent their recurrence to achieve compliance with regulations.

Uploaded by

Buddy Kertun
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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 3 to 5.


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

MAJOR

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) date dd/mm/yyyy
Comment(s)
(2) (4) (Yes / No)
(1) (3) (5) (6)
(7)

For FDA use only:


Remarks

Recommendation(to FDA office):

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

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


by:

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

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