FDA Inspection
Granules Pharmaceuticals Inc.Granules Pharmaceuticals Inc. – FDA Inspection, Dec 8, 2017
Record Details
This FDA Inspection record concerns Granules Pharmaceuticals Inc., with an inspection on December 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 365993a1-7a71-474c-9726-9ded32a3e0ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035023
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Granules Pharmaceuticals Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2026 | VAI | Baltimore District Office | Drug Quality Assurance |
| June 27, 2025 | VAI | Baltimore District Office | Generic Drug Evaluation |
| December 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Granules Pharmaceuticals Inc.
- FDA Inspection 1311002 - 2026-04-03
- FDA Inspection 1274604 - 2025-06-27
- FDA Inspection 1225087 - 2023-12-15
- FDA Inspection 1215034 - 2023-08-03
- FDA Inspection 1175097 - 2022-07-22
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