Apotek Production & Laboratorier AB
Form 483 issued January 29, 2026 · Umea, Sweden
- Inspection
- Jan 21 – Jan 29, 2026
- Investigator
- Anastasia M. Shields
- Observations
- 9
- Pages
- 7
- FEI number
- 3003766921
In short: On January 29, 2026, FDA issued a Form 483 with 9 observations to Apotek Production & Laboratorier AB in Umea, Vasterbotten (FEI 3003766921) after an inspection that ran Jan 21 – Jan 29, 2026. The investigator was Anastasia M. Shields. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmApotek Production & Laboratorier AB history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apotek Production & Laboratorier AB?
FDA listed 9 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Apotek Production & Laboratorier AB?
Anastasia M. Shields is named on this Form 483, for the inspection of Jan 21 – Jan 29, 2026. Each investigator has a profile showing what they cite most.
When was Apotek Production & Laboratorier AB inspected by FDA?
The inspection ran Jan 21 – Jan 29, 2026, and the Form 483 is dated January 29, 2026.
How do I get the full Form 483 for Apotek Production & Laboratorier AB?
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