FDA Inspection 1225087 — Granules Pharmaceuticals Inc.
The FDA completed an inspection of Granules Pharmaceuticals Inc. on Dec 15, 2023 in Chantilly, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chantilly, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |