FDA Inspection
Granules Pharmaceuticals Inc.Granules Pharmaceuticals Inc. – FDA Inspection, Apr 3, 2026
Record Details
This FDA Inspection record concerns Granules Pharmaceuticals Inc., with an inspection on April 3, 2026, issued by the Baltimore District Office, covering human drugs.
View Company Profile
ID · 920e888f-8fba-4596-ac5e-b8a55ca5eb4f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1311002
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.58Buildings not maintained in good state of repair
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Granules Pharmaceuticals Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| August 21, 2019 | Not classified | Baltimore District Office |
Other documents for Granules Pharmaceuticals Inc.
- FDA Inspection 1274604 - 2025-06-27
- FDA Inspection 1225087 - 2023-12-15
- FDA Inspection 1215034 - 2023-08-03
- FDA Inspection 1175097 - 2022-07-22
- FDA Inspection 1107374 - 2019-08-21
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.