FDA Inspection 1261255 — McKenna Labs Inc
The FDA completed an inspection of McKenna Labs Inc on February 13, 2025 in Fullerton, CA. 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
- February 13, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fullerton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |