FDA Inspection 1253841 — SOHM, Inc.
The FDA completed an inspection of SOHM, Inc. on November 5, 2024 in Vista, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 5, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |