FDA Inspection
Bell-More Labs, Inc.Bell-More Labs, Inc. – FDA Inspection, Mar 13, 2015
Record Details
This FDA Inspection record concerns Bell-More Labs, Inc., with an inspection on March 13, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bell-More Labs, Inc.
- Inspection Date
- March 13, 2015
- Product Type
- Drugs
View Company Profile
ID · 374910ea-66a8-4e92-b61a-8bfc59607e27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918971
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 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 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.113(b)Procedures for sterile drug products
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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 |
| September 26, 2018 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 26, 2016 | OAI | 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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