FDA Inspection
Bello Bio LLCBello Bio LLC – FDA Inspection, Dec 16, 2025
Record Details
This FDA Inspection record concerns Bello Bio LLC, with an inspection on December 16, 2025, issued by the Denver District Office, covering biologics.
- Office
- Denver District Office
- People
- Emily J Mogann (Issuing Officer)
- Emily S. McGann
- Garrad R. Poole (Investigator)
- Laurissa S. Flowers (Issuing Officer)
View Company Profile
ID · 9dd82eec-bac5-440a-af4e-1a68e2426f11
Inspection Facts
- Inspection number
- 1293904
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued, view the record
FDA Citations
16- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.188Prepared for each batch, include complete information
Showing 10 of 16 citations.
Full citation text and observation details available on the Dashboard.
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.