FDA Inspection
Omega Tech Labs, LLCOmega Tech Labs, LLC – FDA Inspection, Jan 22, 2024
Record Details
This FDA Inspection record concerns Omega Tech Labs, LLC, with an inspection on January 22, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d411623d-2457-45b7-b030-170b0f7bf4da
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1227531
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Omega Tech Labs, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2025 | OAI | Seattle District Office | Drug Quality Assurance |
| August 25, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 3, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 2, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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