FDA Inspection 661423 — Chattem Inc
The FDA completed an inspection of Chattem Inc on May 13, 2010 in Morristown, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 13, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Morristown, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6736 | 21 CFR 314.80(c)(1)(ii) | Submission of report follow-up |
| 8917 | 21 CFR 314.81(b)(2)(vi)(b) | Completed, unpublished clinical trials |
| 8922 | 21 CFR 314.81(b)(2)(viii) | Post marketing study status report for other studies |