FDA Inspection 787476 — Pharmco Laboratories Inc.
The FDA completed an inspection of Pharmco Laboratories Inc. on June 21, 2012 in Titusville, FL. 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
- June 21, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Titusville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15437 | 21 CFR 111.15(a)(1) | Grounds - equipment, litter, weeds |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15883 | 21 CFR 111.75(i) | Corrective action plan |
| 15922 | 21 CFR 111.95(b)(3) | Documentation - ensure specifications met |
| 15923 | 21 CFR 111.95(b)(4) | Documentation - specifications met; test, examinations |
| 15969 | 21 CFR 111.117(d) | Quality control operations - equipment functions |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 16083 | 21 CFR 111.35(b)(6) | Documentation - equipment functions; intended use |