FDA Inspection
Bell-More Labs, Inc.Bell-More Labs, Inc. – FDA Inspection, Sep 26, 2018
Record Details
This FDA Inspection record concerns Bell-More Labs, Inc., with an inspection on September 26, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · c4b316e3-a12f-46c5-a95f-95c3c285dfe1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1066757
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Bell-More Labs, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2024 | Not classified | Baltimore District Office | Drug Quality Assurance |
| June 7, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 26, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2013 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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