FDA Inspection 1252094 — Chattem Inc
The FDA completed an inspection of Chattem Inc on Aug 22, 2025 in Chattanooga, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 22, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chattanooga, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |