FDA Inspection
Orbbo Biotechnology LLCOrbbo Biotechnology LLC – FDA Inspection, May 2, 2018
Record Details
This FDA Inspection record concerns Orbbo Biotechnology LLC, with an inspection on May 2, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Person
- Cara M. Minelli (Issuing Officer)
View Company Profile
ID · 5bac34cb-2ab8-4a06-a79b-8696fd6581ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052281
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.200(c)Calibrated per established schedules
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.260(e)Periodic review of temperatures
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.