FDA Inspection 986391 — Omega Tech Labs, Inc.
The FDA completed an inspection of Omega Tech Labs, Inc. on Aug 25, 2016 in Boise, ID. 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
- Aug 25, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |