Rechon Life Science AB
Form 483 issued March 17, 2023 · Limhamn, Sweden
- Inspection
- Mar 9 – Mar 17, 2023
- Observations
- 4
- Pages
- 8
- FEI number
- 3002806978
In short: On March 17, 2023, FDA issued a Form 483 with 4 observations to Rechon Life Science AB in Limhamn, Sweden (FEI 3002806978) after an inspection that ran Mar 9 – Mar 17, 2023. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Written procedures are not established and followed that describe the in-process controls and examinations to be…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Questions about this 483
What did FDA find at Rechon Life Science AB?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was Rechon Life Science AB inspected by FDA?
The inspection ran Mar 9 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
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.