Merz Pharma GmbH & Co KGaA
Form 483 issued November 22, 2019 · Dessau-Rosslau, Germany
- Inspection
- Nov 14 – Nov 22, 2019
- Investigators
- Susan T. Hadman· Yumi J. Hiramine
- Observations
- 4
- Pages
- 3
- FEI number
- 3006896175
In short: On November 22, 2019, FDA issued a Form 483 with 4 observations to Merz Pharma GmbH & Co KGaA in Dessau-Rosslau, Germany (FEI 3006896175) after an inspection that ran Nov 14 – Nov 22, 2019. The investigators were Susan T. Hadman and Yumi J. Hiramine. Most observations concern laboratory controls and biologics CGMP.
At a glance
Laboratory controls and biologics cgmp 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
Failure to submit biological…
- 02
The accuracy of test methods…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate designed to assure that…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Susan T. Hadman
7 documents · 2009–2024
Cites 211.42(a) (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmMerz Pharma GmbH & Co KGaA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 600.14
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merz Pharma GmbH & Co KGaA?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, biologics CGMP and production. The opening words of each observation are shown on this page.
Who inspected Merz Pharma GmbH & Co KGaA?
Susan T. Hadman and Yumi J. Hiramine are named on this Form 483, for the inspection of Nov 14 – Nov 22, 2019. Each investigator has a profile showing what they cite most.
When was Merz Pharma GmbH & Co KGaA inspected by FDA?
The inspection ran Nov 14 – Nov 22, 2019, and the Form 483 is dated November 22, 2019.
How do I get the full Form 483 for Merz Pharma GmbH & Co KGaA?
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.