FDA Inspection 1239312 — Pace Analytical Services, LLC
The FDA completed an inspection of Pace Analytical Services, LLC on May 23, 2024 in Williamsport, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 23, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Williamsport, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |