FDA Inspection
King Bio Inc.King Bio Inc. – FDA Inspection, Jul 28, 2023
Record Details
This FDA Inspection record concerns King Bio Inc., with an inspection on July 28, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6b5f9ee1-0c19-4ad4-8fc4-6190f3ec9e33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215129
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of King Bio Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| September 4, 2015 | 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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