FDA Inspection 1022374 — Vege Labs LLC
The FDA completed an inspection of Vege Labs LLC on May 5, 2017 in Glendale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 19 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 5, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |