FDA Inspection
AndersonBrecon (UK) LimitedAndersonBrecon (UK) Limited – FDA Inspection, Jan 18, 2018
Record Details
This FDA Inspection record concerns AndersonBrecon (UK) Limited, with an inspection on January 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fc526c29-f9b3-496e-bfa9-50eef40903ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038235
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of AndersonBrecon (UK) Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 27, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 13, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for AndersonBrecon (UK) Limited
- FDA Inspection 1243845 - 2024-04-05
- FDA Inspection 1148651 - 2019-06-27
- FDA Inspection 946444 - 2015-10-13
- FDA Inspection 716711 - 2011-02-24
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