FDA Inspection 950468 — Lina Gale Inc.
The FDA completed an inspection of Lina Gale Inc. on Nov 30, 2015 in Walnut, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 30, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Walnut, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |