FDA Inspection
Bell-More Labs, Inc.Bell-More Labs, Inc. – FDA Inspection, May 26, 2016
Record Details
This FDA Inspection record concerns Bell-More Labs, Inc., with an inspection on May 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bell-More Labs, Inc.
- Inspection Date
- May 26, 2016
- Product Type
- Drugs
View Company Profile
ID · 1fecb4fa-4b7d-463c-b247-4d101509291d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 979342
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
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 |
| 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.