Rommelag CDMO Switzerland AG
Form 483 issued February 11, 2022 · Zell, Switzerland
- Inspection
- Jan 31 – Feb 11, 2022
- Observations
- 3
- Pages
- 2
- FEI number
- 3004079469
In short: On February 11, 2022, FDA issued a Form 483 with 3 observations to Rommelag CDMO Switzerland AG in Zell, LU (FEI 3004079469) after an inspection that ran Jan 31 – Feb 11, 2022. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
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 are not…
- 02
Written records are not always made of investigations…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Questions about this 483
What did FDA find at Rommelag CDMO Switzerland AG?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
When was Rommelag CDMO Switzerland AG inspected by FDA?
The inspection ran Jan 31 – Feb 11, 2022, and the Form 483 is dated February 11, 2022.
How do I get the full Form 483 for Rommelag CDMO Switzerland AG?
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.