FDA Inspection 1182140 — PQ Pharmacy LLC
The FDA completed an inspection of PQ Pharmacy LLC on Oct 27, 2022 in Brooksville, FL. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 27, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 21422 | FDCA 503B(b)(2)(A) | Outsourcing facility, compounded drug report follow up |
| 21423 | FDCA 503B(b)(2)(A) | Outsourcing facility, compounded drug report during registration |