# FDA 483 - Ames Goldsmith Corporation - March 06, 2020

Source: https://www.globalkeysolutions.net/records/483/ames-goldsmith-corporation/73369fe2-25d1-468a-b05c-8cc752a04621

> FDA 483 for Ames Goldsmith Corporation on March 06, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ames Goldsmith Corporation
- Inspection Date: 2020-03-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Ames Goldsmith Corporation, an Active Pharmaceutical Ingredient (API) manufacturer in Glens Falls, NY, was cited for multiple repeat observations during an FDA inspection. The inspection revealed significant deficiencies in quality control, including inadequate investigations into batch discrepancies, lack of validated manufacturing processes and equipment, and insufficient stability studies for Silver Nitrate USP. These issues indicate a systemic failure to adhere to good manufacturing practices.

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- [483 - 2025-05-22](https://www.globalkeysolutions.net/records/483/ames-goldsmith-corporation/90801da1-052d-4e81-812a-30142a6f1579)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.globalkeysolutions.net/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961