FDA Inspection
Cephazone Pharma, LLCCephazone Pharma, LLC – FDA Inspection, Oct 17, 2018
Record Details
This FDA Inspection record concerns Cephazone Pharma, LLC, with an inspection on October 17, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 5f4f5614-ffcc-493f-81ff-f26d250a6e0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069068
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Cephazone Pharma, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2016 | Not classified | Los Angeles District Office | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 8, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 9, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 31, 2013 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| November 17, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Cephazone Pharma, LLC
- FDA Inspection 992709 - 2016-11-10
- FDA Inspection 929906 - 2015-06-08
- FDA Inspection 862205 - 2014-01-09
- FDA Inspection 816474 - 2013-01-31
- FDA Inspection 754526 - 2011-11-17
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