FDA Inspection
Bora Pharmaceuticals Injectables IncBora Pharmaceuticals Injectables Inc – FDA Inspection, Aug 10, 2023
Record Details
This FDA Inspection record concerns Bora Pharmaceuticals Injectables Inc, with an inspection on August 10, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d74ab50e-d1c8-4726-a906-4fd1fc894da0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215798
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.63Equipment Design, Size and Location
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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 |
| 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 1308344 - 2026-03-20
- FDA Inspection 1236852 - 2024-07-25
- FDA Inspection 1162959 - 2022-02-18
- FDA Inspection 1140286 - 2021-04-16
- FDA Inspection 1091850 - 2019-05-10
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