Rommelag CDMO GmbH
Form 483 issued February 18, 2020 · Sulzbach-Laufen, Germany
- Inspection
- Apr 10, 2019 – Feb 18, 2020
- Investigator
- Hugh M. McClure
- Observations
- 5
- Pages
- 13
- FEI number
- 3002808845
In short: On February 18, 2020, FDA issued a Form 483 with 5 observations to Rommelag CDMO GmbH in Sulzbach-Laufen, Germany (FEI 3002808845) after an inspection that ran Apr 10, 2019 – Feb 18, 2020. The investigator was Hugh M. McClure. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The written stability testing…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Hugh M. McClure
5 documents · 2013–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Texas.
The firmRommelag CDMO GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rommelag CDMO GmbH?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Rommelag CDMO GmbH?
Hugh M. McClure is named on this Form 483, for the inspection of Apr 10, 2019 – Feb 18, 2020. Each investigator has a profile showing what they cite most.
When was Rommelag CDMO GmbH inspected by FDA?
The inspection ran Apr 10, 2019 – Feb 18, 2020, and the Form 483 is dated February 18, 2020.
How do I get the full Form 483 for Rommelag CDMO GmbH?
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.