FDA Inspection
Braintree Laboratories, Inc.Braintree Laboratories, Inc. – FDA Inspection, May 6, 2019
Record Details
This FDA Inspection record concerns Braintree Laboratories, Inc., with an inspection on May 6, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7a06d485-daba-48de-a4b8-e0cb9f356ed8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091295
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 312.56(b)Investigator non-compliance
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Other FDA inspections of Braintree Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 4, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 31, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 23, 2009 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Braintree Laboratories, Inc.
- FDA Inspection 1117904 - 2020-01-08
- FDA Inspection 881948 - 2014-06-04
- FDA Inspection 792797 - 2012-07-31
- FDA Inspection 614706 - 2009-09-23
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