# FDA 483 - Ames Goldsmith Corporation - May 22, 2025

Source: https://www.globalkeysolutions.net/records/483/ames-goldsmith-corporation/90801da1-052d-4e81-812a-30142a6f1579

> FDA 483 for Ames Goldsmith Corporation on May 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ames Goldsmith Corporation
- Inspection Date: 2025-05-22
- Product Type: drugs
- Office Name: New York District Office
- Summary: Ames Goldsmith Corp. in Glens Falls, NY, an API manufacturer, received a Form 483 with six observations related to significant quality system deficiencies. These include unqualified manufacturing and laboratory equipment (a repeat observation), inadequate computer system controls, incomplete analytical data, lack of stability studies, insufficient component testing, and failure to investigate product failures. The findings indicate a broad lack of adherence to good manufacturing practices for Silver Nitrate API.

## Related Documents

- [483 - 2020-03-06](https://www.globalkeysolutions.net/records/483/ames-goldsmith-corporation/73369fe2-25d1-468a-b05c-8cc752a04621)

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [Lauren H. Augustyniak](https://www.globalkeysolutions.net/people/lauren-h-augustyniak/bde81fac-921f-494b-969b-38770fceda7e)

Company: https://www.globalkeysolutions.net/companies/ames-goldsmith-corporation/0c9c7a1f-10cc-4a11-9136-632fc42dbd63

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d