Omega Tech Labs, LLC
Form 483 issued August 25, 2016 · Garden City, Idaho
- Inspection
- Aug 8 – Aug 25, 2016
- Investigator
- Christopher R. Czajka
- Observations
- 9
- Pages
- 6
- FEI number
- 3005274476
In short: On August 25, 2016, FDA issued a Form 483 with 9 observations to Omega Tech Labs, LLC in Garden City, Idaho (FEI 3005274476) after an inspection that ran Aug 8 – Aug 25, 2016. The investigator was Christopher R. Czajka. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
There was a failure to handle and store components at all times in a…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 04
Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmOmega Tech Labs, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Omega Tech Labs, LLC?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Omega Tech Labs, LLC?
Christopher R. Czajka is named on this Form 483, for the inspection of Aug 8 – Aug 25, 2016. Each investigator has a profile showing what they cite most.
When was Omega Tech Labs, LLC inspected by FDA?
The inspection ran Aug 8 – Aug 25, 2016, and the Form 483 is dated August 25, 2016.
How do I get the full Form 483 for Omega Tech Labs, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.