Lex Inc.
Form 483 issued February 14, 2018 · Medley, Florida
- Inspection
- Jan 30 – Feb 14, 2018
- Investigators
- Jennifer L. Huntington· Saundrea A. Munroe
- Observations
- 7
- Pages
- 5
- FEI number
- 1031041
In short: On February 14, 2018, FDA issued a Form 483 with 7 observations to Lex Inc. in Medley, Florida (FEI 1031041) after an inspection that ran Jan 30 – Feb 14, 2018. The investigators were Jennifer L. Huntington and Saundrea A. Munroe. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 02
The written stability testing…
- 03
Written procedures are not followed for evaluations conducted at least to review records associated with a…
- 04
Laboratory records do not include a complete record of all data secured in the course of…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lex Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Lex Inc.?
Jennifer L. Huntington and Saundrea A. Munroe are named on this Form 483, for the inspection of Jan 30 – Feb 14, 2018. Each investigator has a profile showing what they cite most.
When was Lex Inc. inspected by FDA?
The inspection ran Jan 30 – Feb 14, 2018, and the Form 483 is dated February 14, 2018.
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.