Rechon Life Science AB
Form 483 issued September 6, 2024 · Limhamn, Sweden
- Inspection
- Aug 26 – Sep 6, 2024
- Observations
- 6
- Pages
- 8
- FEI number
- 3002806978
In short: On September 6, 2024, FDA issued a Form 483 with 6 observations to Rechon Life Science AB in Limhamn, Sweden (FEI 3002806978) after an inspection that ran Aug 26 – Sep 6, 2024. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions Risk Assessment Report QGL-1015-02…
This inspection in context
Questions about this 483
What did FDA find at Rechon Life Science AB?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Rechon Life Science AB inspected by FDA?
The inspection ran Aug 26 – Sep 6, 2024, and the Form 483 is dated September 6, 2024.
How do I get the full Form 483 for Rechon Life Science 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.