FDA Inspection
Bora Pharmaceuticals Injectables IncBora Pharmaceuticals Injectables Inc – FDA Inspection, Mar 20, 2026
Record Details
This FDA Inspection record concerns Bora Pharmaceuticals Injectables Inc, with an inspection on March 20, 2026, issued by the Baltimore District Office, covering human drugs.
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ID · c00b8896-20e8-40cd-8ceb-4c45a9585074
Inspection Facts
- Inspection number
- 1308344
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Bora Pharmaceuticals Injectables Inc
16| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| May 10, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bora Pharmaceuticals Injectables Inc
- FDA Inspection 1236852 - 2024-07-25
- FDA Inspection 1215798 - 2023-08-10
- FDA Inspection 1162959 - 2022-02-18
- FDA Inspection 1140286 - 2021-04-16
- FDA Inspection 1091850 - 2019-05-10
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