FDA Inspection
PuraCap Laboratories LLCPuraCap Laboratories LLC – FDA Inspection, Mar 17, 2016
Record Details
This FDA Inspection record concerns PuraCap Laboratories LLC, with an inspection on March 17, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- PuraCap Laboratories LLC
- Inspection Date
- March 17, 2016
- Product Type
- Drugs
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ID · bb7b2f5f-5eb6-48e1-8722-74c0ec0c07c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 963506
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PuraCap Laboratories LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 11, 2017 | Not classified | Cincinnati District Office |
Other documents for PuraCap Laboratories LLC
- FDA Inspection 1078575 - 2019-01-22
- FDA Inspection 1018341 - 2017-07-11
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