FDA Inspection 1161256 — Sharp Packaging Services, LLC
The FDA completed an inspection of Sharp Packaging Services, LLC on January 28, 2022 in Allentown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 28, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1546 | 21 CFR 211.125(d) | Destruction of excess labels with lot numbers |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |