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FDA Post Licensing Inspection Checklist

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JemVivar
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791 views1 page

FDA Post Licensing Inspection Checklist

fda

Uploaded by

JemVivar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
  • Inspection Agenda: Details the agenda for an inspection meeting, listing the time, location, participants, and scheduled activities.
RFO/CO: NCR/South Luzon | Name of Establishment INSPECTION AGENDA Lifestrong Marketing Inc. Address 98 Busa St., Caloocan, Metro Mani LTO Number LTO - 3000001096838 / 10 November 2018 Date/s of Inspection Within the approved itinerary [Purpose of Inspection Post Licensing Inspection | Reference / Inspection | Standard GDSP, A.O, 2014-0029, R.A. 10611 Inspection Day/Time Inspection Activity z T- Opening Meeting Presentation of inspection plan, attendance sheet |. Document Review : ‘© Valid Proof of Registration: DT Cert/ SEC Registration and Articles of Incorporation ‘© Valid Business Permit © Valid Proof of Occupaney = Contract of Lease / Cen Contract of Lease of Warchouse if any ution agreements with Foreign and Local suppliers ( quality agreements) Supplier's Cenitieates: GMP / HACCP / Certificate of Free Sale / Phytosanitary Cerificate / FSMS 180 2200 ‘+ Valid LTO of Local supplier ‘+ List of Sources and produets and CPRs ‘+ Distribution Records: Sales Invoices, Receipts from suppliers,Recei Standard Operating Procedures for Handling of Prociuct Complaints, Returns and Recall II], Walk-through Inspection 3.1 Personnel '* Duties and Responsibilities © Trainings 41 «SOP for Hygiene and Sanitation 5.2 Premises and Warehouse facilities 3.3 Records © Training Records ‘+ Calibration Records of Temperature Monitoring Devices ‘+ Pest Control service records Stock Reconciliation’ Inventory 3.7 Transport & Dispatch of products © Vehicle Maintenance and monitoring records ‘+ _ Personnel in-charge for transport of products. cate oF Occupaney/TCT z Inspector/s 4 E. Dayao. (Print Naple & Signature) (Print Name & Signature) Food-Drug Regulation Officer Food-Drug Regulation Officer ame Fl (Print Name & Signature) Team Leader, Food-Drug Regulation Officer

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