NextPharma Oy
Form 483 issued September 6, 2022 · TAMPERE, Finland
- Inspection
- Aug 29 – Sep 6, 2022
- Investigator
- Sean R. Marcsisin
- Observations
- 6
- Pages
- 7
- FEI number
- 3016974567
In short: On September 6, 2022, FDA issued a Form 483 with 6 observations to NextPharma Oy in TAMPERE, Finland (FEI 3016974567) after an inspection that ran Aug 29 – Sep 6, 2022. The investigator was Sean R. Marcsisin. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 6 of 6 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
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Sean R. Marcsisin
22 documents · 2016–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Massachusetts.
The firmNextPharma Oy 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 NextPharma Oy?
FDA listed 6 observations on this Form 483, mostly about production 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 NextPharma Oy?
Sean R. Marcsisin is named on this Form 483, for the inspection of Aug 29 – Sep 6, 2022. Each investigator has a profile showing what they cite most.
When was NextPharma Oy inspected by FDA?
The inspection ran Aug 29 – Sep 6, 2022, and the Form 483 is dated September 6, 2022.
How do I get the full Form 483 for NextPharma Oy?
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.