Lex Inc.
FDA inspection history in Medley, Florida, 2018 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Medley, Florida.
- 2018The longest 483 on file: 7 observations over 5 pages at Medley, Florida.
- 2023One warning letter and one Form 483, at Medley, Florida.
Cited most
Across all Lex observations on file
- 21 CFR 211.194Laboratory records4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.180General requirements2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100Written procedures; deviations1
The complete Lex file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Medley, Florida
Two Form 483s and one warning letter · 2018 to 2023 · 13 observations
Latest: Warning letter, Aug 17, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-17 | Warning letter Warning letter | Medley, Florida | — | $99 |
| 2023-02-28 | 483 Form 483 | Medley, Florida | 6 | $99 |
| 2018-02-14 | 483 Form 483 | Medley, Florida | 7 | $99 |
Investigators on these documents
Benita C. Okeke (1)Jennifer L. Huntington (1)Nicole E. Knowlton (1)Saundrea A. Munroe (1)Suzanne N. Vallez (1)
FEI number 1031041 · most recent document Aug 17, 2023
About Lex Inc.
How many FDA Form 483s has Lex Inc. received?
FDA Intel has 2 Form 483s on file for Lex Inc.; the most recent is dated Feb 28, 2023.
When was Lex Inc. last inspected by FDA?
The most recent FDA inspection document on file for Lex Inc. is a Form 483 dated Feb 28, 2023, for the site in Medley, Florida.
What did FDA cite at Lex Inc.?
The regulations cited most in the observations on file for Lex Inc. are 21 CFR 211.194 (Laboratory records), 4 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.180 (General requirements), 2 times.
Has Lex Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lex Inc.; the most recent is dated Aug 17, 2023.