FDA Inspection 800147 — LTS Lohmann Therapy Systems Corp
The FDA completed an inspection of LTS Lohmann Therapy Systems Corp on September 11, 2012 in West Caldwell, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 11, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Caldwell, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |