FDA Inspection
Bioserv CorporationBioserv Corporation – FDA Inspection, Dec 7, 2011
Record Details
This FDA Inspection record concerns Bioserv Corporation, with an inspection on December 7, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bioserv Corporation
- Inspection Date
- December 7, 2011
- Product Type
- Drugs
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ID · cf5d3bc2-11f0-4560-b97c-d452d20f93b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756094
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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Other FDA inspections of Bioserv Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 31, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 23, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 24, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bioserv Corporation
- FDA Inspection 1195989 - 2023-01-12
- FDA Inspection 1022355 - 2017-07-31
- FDA Inspection 863803 - 2014-01-23
- FDA Inspection 804269 - 2012-10-24
- FDA Inspection 656899 - 2010-04-12
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