FDA Inspection
Bryant Ranch Prepack, Inc.Bryant Ranch Prepack, Inc. – FDA Inspection, Dec 15, 2016
Record Details
This FDA Inspection record concerns Bryant Ranch Prepack, Inc., with an inspection on December 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e42e12e9-a27e-4b04-97f4-c31d47a84af8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995337
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Bryant Ranch Prepack, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| January 25, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 17, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 11, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bryant Ranch Prepack, Inc.
- FDA Inspection 1326578 - 2026-07-16
- FDA Inspection 1228907 - 2024-01-25
- FDA Inspection 1165537 - 2022-03-17
- FDA Inspection 1110509 - 2019-11-18
- FDA Inspection 840224 - 2013-07-11
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