FDA Inspection
Tropical Products IncTropical Products Inc – FDA Inspection, Oct 14, 2016
Record Details
This FDA Inspection record concerns Tropical Products Inc, with an inspection on October 14, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · dc4ca69d-df41-434c-b6d3-d50968afea26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989899
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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