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    UCU - Ymana - MAJ - Capa Plan

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    Majesty Ymana
    The document is a corrective and preventive action plan from MJ's Pharmacy addressing deficiencies found during an FDA inspection. [1] The pharmacy was cited for being absent a pharmacist, an expired license to operate, and selling antibiotics without a prescription. [2] The plan outlines corrective actions like hiring a backup pharmacist and no longer selling antibiotics without prescriptions. [3] Preventive actions include always having a replacement pharmacist and requiring prescriptions for antibiotic purchases.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    UCU - Ymana - MAJ - Capa Plan

    Uploaded by

    Majesty Ymana
    112 views3 pages
    The document is a corrective and preventive action plan from MJ's Pharmacy addressing deficiencies found during an FDA inspection. [1] The pharmacy was cited for being absent a pharmacist, an expired license to operate, and selling antibiotics without a prescription. [2] The plan outlines corrective actions like hiring a backup pharmacist and no longer selling antibiotics without prescriptions. [3] Preventive actions include always having a replacement pharmacist and requiring prescriptions for antibiotic purchases.

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    UCU_Ymana_MAJ - Capa Plan

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    The document is a corrective and preventive action plan from MJ's Pharmacy addressing deficiencies found during an FDA inspection. [1] The pharmacy was cited for being absent a pharmacist, an expired license to operate, and selling antibiotics without a prescription. [2] The plan outlines corrective actions like hiring a backup pharmacist and no longer selling antibiotics without prescriptions. [3] Preventive actions include always having a replacement pharmacist and requiring prescriptions for antibiotic purchases.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    112 views3 pages

    UCU - Ymana - MAJ - Capa Plan

    Uploaded by

    Majesty Ymana
    The document is a corrective and preventive action plan from MJ's Pharmacy addressing deficiencies found during an FDA inspection. [1] The pharmacy was cited for being absent a pharmacist, an expired license to operate, and selling antibiotics without a prescription. [2] The plan outlines corrective actions like hiring a backup pharmacist and no longer selling antibiotics without prescriptions. [3] Preventive actions include always having a replacement pharmacist and requiring prescriptions for antibiotic purchases.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3

    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: MJ’s Pharmacy Address: Sison, Pangasinan

    Inspector/s: FDA Inspector Inspection dates: 10/28/2021

    Prepared by : Majesty Ann J. Ymana - Owner Date prepared (dd/mm/yyyy): 14/11/2021


    (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

    N/A N/A N/A N/A N/A N/A


    MAJOR

    CA: Have a backup pharmacist.


    1 Pharmacist is absent Hired a replacement 11/20/2021
    PA: Always have a replacement.
    Licensed to Operate not
    1 CA: Renew the LTO immediately. See Attached file 11/20/2021
    renewed
    Selling Antibiotic without Requires prescription to
    CA: Never sell antibiotic again Immediately after
    1 Prescription patients when buying
    without prescription. the inspection
    antibiotics

    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) Comment(s)
    (2) (4) date dd/mm/yyyy (Yes / No)
    (1) (3) (5) (6)
    (7)
    CA: Replace the ceiling fan with
    Pharmacy temperature
    air conditioner. Waiting for the delivery of
    1 during the time of inspection 11/18/2021
    PA: Ensure proper ventilation to the air conditioner.
    is 35C
    maintaing the quality of products
    Hygrometer - Expired CA: Renew the Calibration
    1 See attached file 11/20/2021
    Calibration Certificate certificate
    CA: Provide pallets for the stock Waiting for the pallets to
    1 Stock room has no pallets 11/18/2021
    room. arrive

    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 2 of 3
    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: 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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