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USFDA Audits / Inspections

If your firm registered with FDA under any regulation as a manufacturer/trader/ distributor for any FDA regulated products, sooner or later, you can expect an inspection from FDA. FDA inspection is conducted worldwide registered facilities to verify compliance with all relevant regulations.

FDA inspection / Audits are mainly classified into four types based on activities carried out in below sectors:

  • Pharmaceutical / Drug manufacturers
  • Medical Device manufacturers
  • Blood banks
  • Nutraceutical / Food Supplement and or Food processing facilities
  • Dairy farms
  • Animal feed processors
  • FDA approved Compounding pharmacies
  • Clinical trial organizations.
  • Pre- Clinical laboratories conduct studies in animals for medical device product

FDA intends to protect the public from unsafe products; the below four different types of an inspection conducted
(a)pre-approval inspection,
(b)routine inspection,
(c)compliance follow-up inspection, and
(d)“for cause” inspection. 
Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.
(a)Pre-Approval Inspections: The type of inspection conducted after a company submits an application to FDA to market a new product.
(b)Routine Inspections: The type of inspection are mandated by law every 2 years once (for class II and class III medical device manufacturers, nutraceutical, cosmetic, food and drug manufactures) 
(c)Compliance Follow-Up Inspections: The type of inspection conducted to review actions taken by a firm/manufacturer in response to a previous inspection that resulted in significant 483 observations or a Warning Letter.
(d)“For Cause” Inspections: The type of inspection conducted to investigate a specific problem that has been reported to FDA. The source of the report can be from the manufacturer or consumer or user or even an employee in the same company. 
I 3 CONSULTING services are designed to provide efficient technical support intended to help manufactures to reduce the finding /observations identified by FDA inspectors.
We have customized expert technical services to suite client requirements covering Food, Medical Device, Pharmaceuticals across the globe from our office locations in USA, INDIA & GERMANY.

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+ 91 994 591 2081
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+1 630 696 1293
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