FDA Inspection 987709 — Chattem Inc

Chattem Inc — FEI 2222017

The FDA completed an inspection of Chattem Inc on Aug 3, 2016 in Morristown, NJ. 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). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Aug 3, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Morristown, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
683521 CFR 314.80(d)Failure to submit scientific article

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