FDA Inspection 1109660 — Carlsbad Technology, Inc
The FDA completed an inspection of Carlsbad Technology, Inc on October 25, 2019 in Carlsbad, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |