FDA Inspection 1115286 — Tekweld Solutions Inc.
The FDA completed an inspection of Tekweld Solutions Inc. on January 17, 2020 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 17, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |