FDA Inspection
Bora Pharmaceuticals Injectables IncBora Pharmaceuticals Injectables Inc – FDA Inspection, Apr 16, 2021
Record Details
This FDA Inspection record concerns Bora Pharmaceuticals Injectables Inc, with an inspection on April 16, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 16, 2021
- Product Type
- Drugs
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ID · 4ebf7275-3291-41e0-8938-0c37b0de7144
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1140286
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
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 |
| May 10, 2019 | NAI | 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 1091850 - 2019-05-10
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