FDA Inspection
Ocubright Tear Stain Remover, Inc.Ocubright Tear Stain Remover, Inc. – FDA Inspection, Jul 16, 2018
Record Details
This FDA Inspection record concerns Ocubright Tear Stain Remover, Inc., with an inspection on July 16, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 8ed3bc92-29b8-4fee-856c-99bfb8a464ca
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1058992
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of Ocubright Tear Stain Remover, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2017 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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