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Organizational Management Personnel: FDA Inspection Checklist

This document provides an inspection checklist for the FDA to evaluate an organization's quality management system and warehouse facilities. The checklist includes reviewing organizational documents, performing a walkthrough inspection of the warehouse, and collecting samples. The inspection focuses on assessing the organization's management of personnel, quality system, risk management, standard operating procedures, records, contracts, facilities, storage conditions, product handling, and transport processes. Documentation that would also be requested includes licenses, permits, certificates, lists of products and suppliers, agreements, and standard operating procedures.

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169 views2 pages

Organizational Management Personnel: FDA Inspection Checklist

This document provides an inspection checklist for the FDA to evaluate an organization's quality management system and warehouse facilities. The checklist includes reviewing organizational documents, performing a walkthrough inspection of the warehouse, and collecting samples. The inspection focuses on assessing the organization's management of personnel, quality system, risk management, standard operating procedures, records, contracts, facilities, storage conditions, product handling, and transport processes. Documentation that would also be requested includes licenses, permits, certificates, lists of products and suppliers, agreements, and standard operating procedures.

Uploaded by

regina dela cruz
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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FDA Inspection checklist

 Document Review:
Organizational Management Personnel
-Organizational Chart/Management Description/Duties and Responsibilities
-Training Plan/Records/Competency evalutation
QMS Evaluation
-LTO/CPR
-Risk Management Plan
-Standard Operating Procedures (SOP)
-Records (Importation/Distribution/Deliveries,complain,recall)
Contract Activites
-Quality Agreement with suppliers / sources
-GMP Certificate/Free Sale/Phytosanitary Cert and other equivalent documents
-Franchise agreement (if applicable)

 Walk through Inspection


Warehouse facilities
-Premises (Sanitation, Sanitation program, pest control, housekeeping, ventilation, lights)
-Storage fixtures (pallets, cabinets,steel racks)
-Storage Equipment (Temperature monitors)
-Storage area/segregated areas for recalled/damaged/expired/returned products
-Storage condition (Stock Rotation and arrangement)
-Records (temperature and RH, calibration, Stock Reconciliation/ Inventory, Dispatch)
Products physical examination / collection of samples
Transport and Dispatch of products
-Vehicle Maintenance, Personnel, Compliance to Storage Requirements

Will also be needing:

-LTO
-DTI Certificate / SEC Registration with Articles of Incorporation / Cert. Of Cooperative
Development Authority (if Cooperative)
-Mayor’s Business Permit / Brgy. Clearance (if the business name and/or address is different
from the registered name and/or address in the DTI / SEC)
-Notarized Proof of Occupancy / Lease Contract / Transfer Certificate of Title
(Office/Warehouse/Stock Room)
-List of Products and copy of valid Certificate of Product Registration (for LTO renewal/PLI)
-List of Suppliers / Sources (foreign/local)
-Franchise agreement (if applicable)
-Suppliers Documents
For Local Supplier
Copy of valid LTO of Toll Manufacturer / Repacker
Notarized Toll Packing / Food Manufacturing / Repacking Agreement (including
warehousing & logistics services)
-Distribution Records/Sales Invoice
-Standard Operating Procedures for:
a.Handling Product Recall, Complaints and Returns
b. Pest Control including Service Records / Contract
c. Stock Management Control
d. Dispatching & Transporting of Products
e. Cleaning & Sanitation
f. Equipment Maintenance including Calibration Records of Temperature Devices (if applicable)
-Duties and Responsibilities / Trainings of the warehouse personnel

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