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: SMB Pharmacy Address: Ilocos Norte

Inspector/s: Inspection dates: 07/02/2020

Prepared by : Sheila Marie A. Balbas Date prepared (dd/mm/yyyy): 06/02/2020

(Name & Designation of establishment’s authorized representative)

Note: Establishment to fill columns 1 to 5.

Completion or Response
Deficiency Corrective Action /Preventive Inspector(‘s)
Description of deficiency Evidence of compliance proposed completion accepted
number Actions (CAPA) Comment(s)
(2) (4) date dd/mm/yyyy (Yes / No)
(1) (3) (5) (6)
(7)
CRITICAL
CORRECTIVE: Remove 07/07/2020 YES
 Hygrometer - Expired thermometers and
Calibration  thermometer/hygrometers
requiring vendor calibration
when the calibration expires.

PREVENTIVE: Before the

calibration expires, check and
remove the expired calibration
from service

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28 Corrective Action and Preventive Action Plan Page 1 of 5
 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)

YES

MAJOR

Selling Antibiotic without 07/07/2020 YES

Prescription CORRECTIVE: identify who is
the dispenser to prevent
recurrence

PREVENTIVE: supervise
dispense medicines to prevent YES
occurrence and prevent 07/07/2020
antimicrobial resistance

Pharmacy Temperature YES

during the time of
inspection is 35C CORRECTIVE: Preventive
maintenance on all temperature-
controlled rooms or equipment

PREVENTIVE: inspect pharmacy 07/07/2020

temperature anytime

Stock room has no pallets 

Date Effective: 02 July 2018 Rev 01
Form No. QWP-FROO-06 Annex 28 Corrective Action and Preventive Action Plan Page 2 of 5
 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)

CORRECTIVE:ensure that
there’s a pallets before stocking
new medicines

PREVENTIVE: improvised,
create a wooden pallet.

CORRECTIVE: Renewal of LTO

shall be on the anniversary of its
issuance and shall be valid for
three years.
Licensed to Operate not
07/07/2020 YES
renewed PREVENTIVE: Application for
renewal shall be done within
three (3) months prior to
validity date of the LTO.

MINOR
Pharmacist is absent  CORRECTIVE: Be able to return 07/07/2020 YES
to the pharmacy with reasonable
promptness

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28 Corrective Action and Preventive Action Plan Page 3 of 5
 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)

PREVENTIVE: pharmacist-in-
charge must be identified and
the cedential submitted.

For FDA use only:

Remarks

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28 Corrective Action and Preventive Action Plan Page 4 of 5
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

Recommendation(to FDA office):

07/02/2020
Reviewed Name /Designation and Signature of FDRO(s) Date:
by:
07/02/2020
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 5 of 5