FDA Inspection
King Bio Inc.King Bio Inc. – FDA Inspection, Sep 4, 2015
Record Details
This FDA Inspection record concerns King Bio Inc., with an inspection on September 4, 2015, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- King Bio Inc.
- Inspection Date
- September 4, 2015
- Product Type
- Veterinary
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ID · d8612f97-b4df-4a5e-9a6b-7fe5284758a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941497
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
14- 21 CFR 211.46(d)Penicillin air handling systems not kept separate
- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.176Failing to test for penicillin cross-contamination
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.42(c)(4)In-Process Material Area
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.42(d)Penicillin processing area not kept separate
Showing 10 of 14 citations.
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Other FDA inspections of King Bio Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 20, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 2, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 15, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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