FDA Inspection 1231002 — Pharmco Laboratories Inc.
The FDA completed an inspection of Pharmco Laboratories Inc. on Mar 20, 2025 in Titusville, 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 20, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Titusville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |