FDA Inspection 1089889 — CBI Laboratories, Inc.
The FDA completed an inspection of CBI Laboratories, Inc. on May 14, 2019 in Fort Worth, TX. 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
- May 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (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 |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |