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Know these before you apply for an FDA facility inspection
by John Smith Digital Marketing ExpertRegistering with FDA (U.S. Food and Drug Administration) demands your complete consent to receive an inspection at your facility, with or without notice. FDA facility inspections depend on several aspects, including your proximity to another company that the FDA is already visiting.
What to expect from an FDA inspection?
An FDA inspection can take anywhere from 2 to 5 days. During this time, the inspector can assess the compliance of the company and establishment through –
Good manufacturing practices
FDA registered food establishments must comply with Current Good Manufacturing Practices (CGMPs) on the following points –
- Factory Construction and Maintenance
- Employee Hygiene,
- Manufacturing Operations
Requirements under preventive controls
This specific rule allows the specific facilities to implement risk-based preventive controls plans and hazard analysis. These include –
- An analysis of known and reasonably foreseeable food risks,
- Preventive controls for identified hazards,
- Adequate procedures for monitoring preventive controls.
General food security violations
There are some food security violations that are strictly followed by FDA facility inspection team.
- Sanitation Monitoring: The FDA often cites facilities for not monitoring sanitation conditions often enough, such as water safety, preventing cross-contamination and maintaining hygiene facilities.
- Pest Control: The FDA often cites facilities for not adequately excluding pests that can contaminate food.
- Manufacturing, processing, packaging and storage controls: The FDA may cite a facility for failing to implement adequate controls to mitigate the risk of food hazards, such as the growth of microorganisms, cross-contact with allergens and food contamination.
- Sanitary operations and factory maintenance: The FDA may quote a facility for failing to maintain factory cleanliness, or for not maintaining a good state of repair.
- Personnel: The FDA facility inspection is strict with not providing general measures and precautions for the staffs (failure in hygiene and cleanliness).
In-depth view of FDA inspection
FDA is a federal agency. It works directly under the HHS (Department of Health and Human Services). It is accountable for –
- Promote, evaluate and protect public health. It ensures that food and dietary supplements are up to the quality mark and safe for humans,
- Regulate medicines and other biomedical products, such as medical devices for safety and effectiveness,
- Regulating tobacco products,
- Regulating cosmetic products for safety,
- Regulation of living organisms,
- Make sure that all of these products are labeled appropriately and consistently,
- Leading public health and safety efforts, helping to accelerate product innovation.
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About John Smith 
Digital Marketing Expert
343 connections, 4 recommendations, 973 honor points.Joined APSense since, June 14th, 2012, From Delhi, India.
Created on Feb 1st 2021 23:15. Viewed 196 times.
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