A.I.G Technologies Inc.September 25, 2019

FDA 483 - A.I.G Technologies Inc. - September 25, 2019

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Record Details

A-16 Technologies, Inc. in Pompano Beach, FL, received a Form 483 with three observations during an inspection of their manufacturing facility. The firm failed to properly utilize stability testing results for determining expiration dates and exhibited significant deficiencies in their investigation records for unexplained discrepancies. Additionally, master production and control records were found to be incomplete, specifically regarding packaging components.

Company: A.I.G Technologies Inc.
Inspection Date: September 25, 2019
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Ariel Cruz Figueroa (Retired)

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ID · 439982d2-1394-42f7-998d-bf8ad9ff1b34