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: Pharmacare Address: 123B Tavera St. Pakil, Laguna

Inspector/s: Jemimah Laguerta, RPh Inspection dates: 1 September 2021

Prepared by: Jersey Ann Marie V. Macalincag, RPh Date prepared (dd/mm/yyyy): 2 September 2021
(Name & Designation of establishment’s authorized representative)

Note: Establishment to fill columns 1 to 5.

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

CORRECTIVE: Talk to the

costumer that you cannot dispense an
antibiotic without a prescription.

Selling Antibiotic without PREVENTIVE: Provides poster

1 4 September 2021
Prescription about antimicrobial resistance and
policy about the prohibition of
dispensing drug without prescription
inside and outside the pharmacy

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28
Corrective Action and Preventive Action Plan Page 1 of 4
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

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

CORRECTIVE: Close the pharmacy

and apply for new LTO in the FDA
eServices Portal
Licensed to Operate not
1 1 October 2021
renewed PREVENTIVE: Make sure to renew
the LTO 3 months before the
expiration

CORRECTIVE: Close the pharmacy

PREVENTIVE:
2 Pharmacist is absent 4 September 2021
 Add a Reliever Pharmacist
 Arrange the pharmacist
shifting schedule

OTHERS

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28
Corrective Action and Preventive Action Plan Page 2 of 4
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

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

PREVENTIVE:
 Always do temperature
Pharmacy Temperature
monitoring
1 during the time of inspection 4 September 2021
 Ensure there is an adequate
is 35C
Air Ventilation, Air
Circulation inside the
pharmacy

CORRECTIVE: Remove the

hygrometer and recalibrate it.
Hygrometer - Expired
2 2 September 2021
Calibration  PREVENTIVE: Calibrate the
hygrometer regularly

CORRECTIVE & PREVENTIVE:

3 Stock room has no pallets 4 September 2021
Provides pallets in the stockroom

Date Effective: 02 July 2018 Rev 01

Form No. QWP-FROO-06 Annex 28
Corrective Action and Preventive Action Plan Page 3 of 4
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

For FDA use only:

Remarks

Recommendation(to FDA office):

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 4 of 4