Meribel Pharma Strangnas AB
Form 483 issued September 6, 2019 · Strangnas, Sweden
- Inspection
- Sep 2 – Sep 6, 2019
- Investigator
- Tenzin Jangchup
- Observations
- 10
- Pages
- 6
- FEI number
- 3006524831
In short: On September 6, 2019, FDA issued a Form 483 with 10 observations to Meribel Pharma Strangnas AB in Strangnas, Sweden (FEI 3006524831) after an inspection that ran Sep 2 – Sep 6, 2019. The investigator was Tenzin Jangchup. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
Most cited: 21 CFR 211.25 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Routine calibration of mechanical equipment is not performed according to a written program designed…
- 04
Sweden Buildings used in the manufacture, processing, packing or holding of drug products are not free…
This inspection in context
Tenzin Jangchup
14 documents · 2015–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmMeribel Pharma Strangnas AB history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meribel Pharma Strangnas AB?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Meribel Pharma Strangnas AB?
Tenzin Jangchup is named on this Form 483, for the inspection of Sep 2 – Sep 6, 2019. Each investigator has a profile showing what they cite most.
When was Meribel Pharma Strangnas AB inspected by FDA?
The inspection ran Sep 2 – Sep 6, 2019, and the Form 483 is dated September 6, 2019.
How do I get the full Form 483 for Meribel Pharma Strangnas AB?
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.