Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-04-28.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Apr 2022 – 28 Apr 2022 | Human Drugs | Clean | |
| 28 May 2018 – 1 Jun 2018 | Human Drugs | 483 | View 483 → |
| 12 Oct 2015 – 13 Oct 2015 | Human Drugs | 483 | On file |
| 9 Jun 2014 – 13 Jun 2014 | Human Drugs | 483 | View 483 → |
| 15 Dec 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Jun 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Liming Zhang
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Liming Zhang1 insp.
Justin A Boyd1 insp.
Emily J Orban1 insp.
Mark R Mcclain1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Apotek Produktion & Laboratorier AB's 3 Form 483s
Source PDFs, 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