FDA Inspection
Peter Thomas Roth Labs, LLCPeter Thomas Roth Labs, LLC – FDA Inspection, May 16, 2012
Record Details
This FDA Inspection record concerns Peter Thomas Roth Labs, LLC, with an inspection on May 16, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Peter Thomas Roth Labs, LLC
- Inspection Date
- May 16, 2012
- Product Type
- Drugs
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ID · 8ce37fef-ed51-4ac8-8dba-cc0d8b4a9789
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779870
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
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Other FDA inspections of Peter Thomas Roth Labs, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2011 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Peter Thomas Roth Labs, LLC
- FDA Inspection 716455 - 2011-03-21
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