FDA Inspection
Product Quest Manufacturing LLCProduct Quest Manufacturing LLC – FDA Inspection, Jan 27, 2017
Record Details
This FDA Inspection record concerns Product Quest Manufacturing LLC, with an inspection on January 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · f319cb49-16a3-4fa3-9e5b-fd0f8b88e230
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000036
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Product Quest Manufacturing LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2012 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Product Quest Manufacturing LLC
- FDA Inspection 948191 - 2015-11-06
- FDA Inspection 915252 - 2015-02-18
- FDA Inspection 771513 - 2012-03-11
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