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Business and Management

What does FDA inspect?

The FDA announced in July that it plans to continue vetting multiple regulated sites in the US this week. However, it is unclear how to decide which sites to visit and what alternative surveillance strategies to use when on-site inspections are difficult.

 However, repeated cases of COVID-19 in the US appear to limit actual inspections and the FDA should rely more on "virtual" or "paper inspection" inspections. You can find various info on the web about FDA inspection 483.

The FDA reviews manufacturers or processors of FDA-regulated products to ensure that they comply with applicable regulations. Property being checked

Producers of vaccines and drugs

Blood bank

Food processing plant

Dairy farm

Animal feed processor

Mix pharmacy

The FDA is also checking

Institutions conducting human studies (clinical studies)

Laboratories that carry out tests on animals or microorganisms while testing are used to apply for FDA approval for a drug

overseas locations for the manufacture and processing of FDA-regulated products sold in the United States

imported products that are regulated at the border

The FDA performs several types of inspections to protect consumers from hazardous products:

A pre-approval review after a company submits an application to the FDA to bring a new product to market

Routine inspection of regulated equipment

A "cause" test to investigate a specific problem with which the FDA is known

The FDA makes certain frequently requested records available for public review in electronic reading rooms. You will need to request freedom of information to get another record.