FDA Inspection 1227531 — Omega Tech Labs, Inc.
The FDA completed an inspection of Omega Tech Labs, Inc. on Jan 22, 2024 in Boise, ID. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 22, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |