FDA Inspection
Majestic Drug Co IncMajestic Drug Co Inc – FDA Inspection, Dec 19, 2016
Record Details
This FDA Inspection record concerns Majestic Drug Co Inc, with an inspection on December 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 89adce46-ba04-44d8-a732-6486dfd495b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999982
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Majestic Drug Co Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Majestic Drug Co Inc
- FDA Inspection 809562 - 2012-11-29
- FDA Inspection 701650 - 2010-10-26
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