FDA Inspection
Bora Pharmaceuticals Laboratories, IncBora Pharmaceuticals Laboratories, Inc – FDA Inspection, Apr 15, 2016
Record Details
This FDA Inspection record concerns Bora Pharmaceuticals Laboratories, Inc, with an inspection on April 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 15, 2016
- Product Type
- Drugs
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ID · 8ff380be-8ea9-40fa-aee8-d0007cb95abf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971066
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Bora Pharmaceuticals Laboratories, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2025 | Not classified | Office of Inspections and Investigations | |
| May 24, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 17, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bora Pharmaceuticals Laboratories, Inc
- FDA Inspection 1273032 - 2025-07-21
- FDA Inspection 1095577 - 2019-05-24
- FDA Inspection 1008321 - 2017-02-17
- FDA Inspection 890281 - 2014-07-26
- FDA Inspection 797513 - 2012-07-26
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