FDA Inspection
Granules Pharmaceuticals Inc.Granules Pharmaceuticals Inc. – FDA Inspection, Oct 26, 2018
Record Details
This FDA Inspection record concerns Granules Pharmaceuticals Inc., with an inspection on October 26, 2018, issued by the Baltimore District Office, covering human drugs.
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ID · 79057046-35e3-4819-a9ee-41f1232ca884
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069969
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.63Equipment Design, Size and Location
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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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