FDA Inspection
PTI Missouri, LLCPTI Missouri, LLC – FDA Inspection, Feb 6, 2018
Record Details
This FDA Inspection record concerns PTI Missouri, LLC, with an inspection on February 6, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7c5dcd89-f5f5-46bf-9821-e7237ff1ff58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041018
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of PTI Missouri, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 15, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2010 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for PTI Missouri, LLC
- FDA Inspection 802884 - 2012-10-12
- FDA Inspection 712293 - 2011-02-15
- FDA Inspection 648146 - 2010-02-18
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