Lex Inc.
Form 483 issued February 28, 2023 · Medley, Florida
- Inspection
- Feb 13 – Feb 28, 2023
- Investigators
- Benita C. Okeke· Nicole E. Knowlton· Suzanne N. Vallez
- Observations
- 6
- Pages
- 12
- FEI number
- 1031041
In short: On February 28, 2023, FDA issued a Form 483 with 6 observations to Lex Inc. in Medley, Florida (FEI 1031041) after an inspection that ran Feb 13 – Feb 28, 2023. The investigators were Benita C. Okeke, Nicole E. Knowlton and Suzanne N. Vallez. Most observations concern quality system 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 quality system.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment is not performed according to…
- 04
The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications…
This inspection in context
Benita C. Okeke
2 documents · 2022–2023
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in Florida.
The firmLex Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lex Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and production. 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 Lex Inc.?
Benita C. Okeke, Nicole E. Knowlton and Suzanne N. Vallez are named on this Form 483, for the inspection of Feb 13 – Feb 28, 2023. Each investigator has a profile showing what they cite most.
When was Lex Inc. inspected by FDA?
The inspection ran Feb 13 – Feb 28, 2023, and the Form 483 is dated February 28, 2023.
How do I get the full Form 483 for Lex Inc.?
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.