FDA Inspection 917528 — LNK International, Inc.
The FDA completed an inspection of LNK International, Inc. on Jan 30, 2015 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |