FDA Inspection 637013 — LNK International, Inc.
The FDA completed an inspection of LNK International, Inc. on Jan 14, 2010 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 14, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1498 | 21 CFR 211.122(b) | Labeling and packaging improperly approved/released |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |