Merz Pharma Gmbh & Co. KGaA
Form 483 issued June 10, 2022 · Reinheim, Germany
- Inspection
- Jun 13 – Jun 16, 2022
- Investigator
- Esteban Beltran
- Observations
- 5
- Pages
- 34
- FEI number
- 3006999111
In short: On June 10, 2022, FDA issued a Form 483 with 5 observations to Merz Pharma Gmbh & Co. KGaA in Reinheim, Germany (FEI 3006999111) after an inspection that ran Jun 13 – Jun 16, 2022. The investigator was Esteban Beltran. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
3 of 5 observations on this 483 concern capa.
Most cited: 21 CFR 820.90 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation activities and results have…
- 02
Corrective and preventive action activities and/or. results have…
- 03
Procedures for rework of nonconforming product have…
- 04
Procedures have not, been adequately established to control product. that, does not…
This inspection in context
Esteban Beltran
9 documents · 2017–2025
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmMerz Pharma Gmbh & Co. KGaA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90
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 5 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Merz Pharma Gmbh & Co. KGaA?
Esteban Beltran is named on this Form 483, for the inspection of Jun 13 – Jun 16, 2022. Each investigator has a profile showing what they cite most.
When was Merz Pharma Gmbh & Co. KGaA inspected by FDA?
The inspection ran Jun 13 – Jun 16, 2022, and the Form 483 is dated June 10, 2022.
How do I get the full Form 483 for Merz Pharma Gmbh & Co. KGaA?
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