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

Source: https://www.keypedia.com/records/483/aig-technologies-inc/439982d2-1394-42f7-998d-bf8ad9ff1b34

> FDA 483 for A.I.G Technologies Inc. on September 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: A.I.G Technologies Inc.
- Inspection Date: 2019-09-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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Company: https://www.keypedia.com/companies/aig-technologies-inc/93f0cba6-de77-4b63-8121-61987aab0949

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6