FDA Inspection 1268075 — Q LABS, LLC
The FDA completed an inspection of Q LABS, LLC on April 25, 2025 in Cincinnati, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |