FDA Inspection 1187498 — Yusef Manufacturing Laboratories, LLC
The FDA completed an inspection of Yusef Manufacturing Laboratories, LLC on November 4, 2022 in Clearfield, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 4, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clearfield, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |