FDA Inspection
OMEZA LLCOMEZA LLC – FDA Inspection, Jul 28, 2023
Record Details
This FDA Inspection record concerns OMEZA LLC, with an inspection on July 28, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 2dbac506-4d02-4a41-bc33-94417215ec46
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1211138
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
12- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
Showing 10 of 12 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.