Tri Tech Laboratories LLC
Form 483 issued December 19, 2023 · New Albany, Ohio
- Inspection
- Dec 6 – Dec 19, 2023
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 9
- Pages
- 9
- FEI number
- 3010165463
In short: On December 19, 2023, FDA issued a Form 483 with 9 observations to Tri Tech Laboratories LLC in New Albany, Ohio (FEI 3010165463) after an inspection that ran Dec 6 – Dec 19, 2023. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
The accuracy and sensitivity of test methods have not…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmTri Tech Laboratories LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tri Tech Laboratories LLC?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Tri Tech Laboratories LLC?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Dec 6 – Dec 19, 2023. Each investigator has a profile showing what they cite most.
When was Tri Tech Laboratories LLC inspected by FDA?
The inspection ran Dec 6 – Dec 19, 2023, and the Form 483 is dated December 19, 2023.
How do I get the full Form 483 for Tri Tech Laboratories LLC?
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