FDA Inspection 1168388 — O.C.C.S. Inc.
The FDA completed an inspection of O.C.C.S. Inc. on Apr 29, 2022 in Stanton, 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 29, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Stanton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |