FDA Inspection 1272865 — HPC Ventures
The FDA completed an inspection of HPC Ventures on Jun 16, 2025 in Hanover, PA. 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hanover, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |