FDA Inspection
Product Quest Manufacturing LLCProduct Quest Manufacturing LLC – FDA Inspection, Feb 18, 2015
Record Details
This FDA Inspection record concerns Product Quest Manufacturing LLC, with an inspection on February 18, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 18, 2015
- Product Type
- Drugs
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ID · a416c0e2-9fc0-43dc-920f-18d4e360399d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 915252
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.180(e)(2)Review of problem drugs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Product Quest Manufacturing LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 6, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2012 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Product Quest Manufacturing LLC
- FDA Inspection 1000036 - 2017-01-27
- FDA Inspection 948191 - 2015-11-06
- FDA Inspection 771513 - 2012-03-11
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