FDA Inspection
Bell-More Labs, Inc.Bell-More Labs, Inc. – FDA Inspection, Apr 3, 2024
Record Details
This FDA Inspection record concerns Bell-More Labs, Inc., with an inspection on April 3, 2024, issued by the Baltimore District Office, covering animal drugs & feeds.
View Company Profile
ID · 96550730-6d1f-4d1e-ad2c-9cb440d4c7f4
Inspection Facts
- Inspection number
- 1234928
- FDA center
- Animal Drugs & Feeds
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bell-More Labs, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| 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 |
Other documents for Bell-More Labs, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.