FDA Inspection 1155119 — Sharp Sterile Manufacturing, LLC
The FDA completed an inspection of Sharp Sterile Manufacturing, LLC on October 15, 2021 in Lee, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 15, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lee, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |