FDA Inspection 1058992 — Ocubright Tear Stain Remover, Inc.
The FDA completed an inspection of Ocubright Tear Stain Remover, Inc. on July 16, 2018 in New York, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 16, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |