FDA Inspection
Bora Pharmaceuticals Injectables IncBora Pharmaceuticals Injectables Inc – FDA Inspection, Dec 20, 2016
Record Details
This FDA Inspection record concerns Bora Pharmaceuticals Injectables Inc, with an inspection on December 20, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 68f803fe-fa10-48b6-ba02-c28f1773d25a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997766
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.194(a)(8)Second person sign off
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Other FDA inspections of Bora Pharmaceuticals Injectables Inc
16| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2026 | Not classified | Baltimore District Office | Drug Quality Assurance |
| July 25, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 10, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 16, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bora Pharmaceuticals Injectables Inc
- FDA Inspection 1308344 - 2026-03-20
- FDA Inspection 1236852 - 2024-07-25
- FDA Inspection 1215798 - 2023-08-10
- FDA Inspection 1162959 - 2022-02-18
- FDA Inspection 1140286 - 2021-04-16
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