FDA Inspection
Prometheus Laboratories Inc.Prometheus Laboratories Inc. – FDA Inspection, Mar 25, 2016
Record Details
This FDA Inspection record concerns Prometheus Laboratories Inc., with an inspection on March 25, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Prometheus Laboratories Inc.
- Inspection Date
- March 25, 2016
- Product Type
- Drugs
View Company Profile
ID · b06146b3-6dcb-4cc2-af6e-0802c1a666c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971015
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Prometheus Laboratories Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 11, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Prometheus Laboratories Inc.
- FDA Inspection 944142 - 2015-09-23
- FDA Inspection 841276 - 2013-07-11
- FDA Inspection 745736 - 2011-09-21
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