FDA Inspection 1077646 — LTS Therapy Systems, LLC
The FDA completed an inspection of LTS Therapy Systems, LLC on January 31, 2019 in Saint Paul, MN. 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
- January 31, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |