FDA Inspection 1264439 — Formulation Technology LLC
The FDA completed an inspection of Formulation Technology LLC on Mar 21, 2025 in Oakdale, CA. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oakdale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 15724 | 21 CFR 111.365(h) | Mechanical steps - contamination |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |