Overview
- 12 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-26.
At a glance
Inspections
12
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jul 2024 – 26 Jul 2024 | Human Drugs | Clean | |
| 6 Dec 2023 – 11 Dec 2023 | Human Drugs | Clean | |
| 14 Nov 2022 – 18 Nov 2022 | Human Drugs | Clean | |
| 14 Mar 2022 – 18 Mar 2022 | Human Drugs | Clean | |
| 17 Oct 2019 – 25 Oct 2019 | Human Drugs | 483 | View 483 → |
| 14 Feb 2018 – 20 Feb 2018 | Human Drugs | 483 | On file |
| 16 Feb 2017 – 24 Feb 2017 | Human Drugs | 483 | View 483 → |
| 22 Jun 2015 – 30 Jun 2015 | Human Drugs | 483 | View 483 → |
| 5 Sep 2013 – 13 Sep 2013 | Human Drugs | 483 | On file |
| 6 Apr 2012 | Not recorded | 483 | View 483 → |
| 1 Oct 2009 | Not recorded | 483 | On file |
| 14 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Oct 2019
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Tonia F Bernard
Investigators
FDA investigators tied to this site in the record.
Ruben C Ayala1 insp.
MRA McCulloughJ1 insp.
Monika Borkowska1 insp.
MRA DavisM1 insp.
Tonia F Bernard1 insp.
Laura Fontan1 insp.
Michael Shanks1 insp.
Scott T Ballard1 insp.
Christopher D Leach1 insp.
Brian D Nicholson1 insp.
Susan T Hadman1 insp.
Dell S Moller1 insp.
Roy C Stephens1 insp.
Barbara D Paul1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lek d.d.'s 7 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat