FDA Inspection
Ocubright Tear Stain Remover, Inc.Ocubright Tear Stain Remover, Inc. – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Ocubright Tear Stain Remover, Inc., with an inspection on March 3, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 8ba12d49-4df1-4571-aec7-3131f57a0c05
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1003358
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Ocubright Tear Stain Remover, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2018 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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