# FDA 483 - Chattem Inc - August 22, 2025

Source: https://www.keypedia.com/records/483/chattem-inc/1124d97e-d527-4a8b-800b-aaadf01694c4

> FDA 483 for Chattem Inc on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chattem Inc
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Chattem Inc. in Chattanooga, TN, revealed significant deficiencies in the firm's quality system and laboratory controls. Observations included a failure to thoroughly investigate out-of-specification events and prolonged open investigations. Additionally, laboratory records were found incomplete regarding reagent identification and documentation of balance zero weights during testing.

## Related Documents

- [483 - 2020-03-13](https://www.keypedia.com/records/483/chattem-inc/0647991c-0755-48a7-8806-17e1c3e38c5f)
- [483 - 2025-08-22](https://www.keypedia.com/records/483/chattem-inc/15050091-b049-4522-8c16-d1d10d68b3d3)

## Related Officers

- [Jeffrey T. Prosterman](https://www.keypedia.com/people/jeffrey-t-prosterman/1343bea3-692d-484e-b29f-c9f8f052f09c)
- [Thuy Tram L. Nguyen](https://www.keypedia.com/people/thuy-tram-l-nguyen/b58f2445-728e-4f79-b7eb-4dfb7e982e25)
- [issuing_officer](https://www.keypedia.com/people/michael-araneta/c94c95f4-2cda-43f5-a02a-2b5d82fe2c7d)

Company: https://www.keypedia.com/companies/chattem-inc/4ca90cd8-88ca-4db8-ad0b-98e339ee0c0a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab