FDA Inspection 1258493 — Tekweld Solutions Inc.
The FDA completed an inspection of Tekweld Solutions Inc. on January 16, 2025 in Hauppauge, NY. 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
- January 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |