Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-29.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2026 – 29 Jan 2026 | Human Drugs | 483 | View 483 → |
| 27 Feb 2023 – 2 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Dec 2018 – 13 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | 483 | On file |
| 26 Sep 2016 – 29 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 2 Mar 2015 – 5 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jan 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Anastasia M Shields
Investigators
FDA investigators tied to this site in the record.
Anastasia M Shields1 insp.
Andrew J Garufi1 insp.
Tania E Vizcaino1 insp.
Patric C Klotzbuecher1 insp.
Edward R Kay1 insp.
Rafael Padilla1 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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Apotek Production & Laboratorier AB's 4 Form 483s
Source PDFs 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