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Decoding all about FDA Facility Inspections! What is Facility Inspection?

FDA Facility inspection is a procedure in which FDA officers overhaul the manufacturer of products that comes under FDA regulations and ensures that they are matching the standards determined by the FDA for the product or not. FDA will contact you to set a date for facility inspection of your product. It takes a time period of 5 days for FDA Facility inspection. Form 482 is issued by the FDA Inspector as notice of inspection which gives the sovereignty to inspect the manufacturing facility. 

Different types of FDA facility Inspection

Four different types of facility inspections are performed by the FDA inspectors for all the facilities which come under the regulations of the FDA. Some examples of facilities that fall under the FDA are - device manufacturers, drug manufacturers, compounding pharmacies, and many others.

  • Pre-approval inspections.
  • Routine inspections.
  • Compliance follow-up inspections.
  • For cause inspections.

Pre-approval inspections: This facility inspection is performed after the submission of application for a new product which the company has to market. After which FDA inspectors concentrate on the data provided in the application and ensures that the company is capable of formulating the product. The benefit of pre-approval facility Inspection is that the inspector will give FDA approval or not.

Routine Inspections: If you are Class II and Class III product manufacturing company then you have to go under routine inspections after every 2 years according to the law. A manufacturer has to be aware and ready for FDA Facility inspection as it can be done any day after the completion of 2 Years.

Compliance follow-up inspections: Earlier if a manufacturer is issued 483 observations or a warning letter by the FDA inspector, then a manufacturer can apply for a Compliance follow-up inspection. This FDA facility inspection is regulated to assure the appropriate rectification of previous infringement.

For cause inspections: This FDA Facility inspection is done if any consumer or employee complaint a problem to the FDA. “For cause” inspection can also be done if any miss happening like death, an accident, or serious harm occurs while using the product of the company.

Different Forms

FDA issued three different types of form during their facility inspection.

  • Form 482: It is issued to notify that FDA inspector will come for routine facility inspection.
  • Form 483: If any violation of rules relating to the Federal Food, Drug, and Cosmetic (FD&C) Act was found then this form will be issued during FDA facility inspection.
  • Form 484: if any samples are acquired during the inspection then form 483 is issued to the same person to whom form 482 was issued as a receipt for samples.
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