THYMOORGAN GMBH PHARMAZIE
Form 483 issued April 25, 2023 · Vienenburg, Germany
- Inspection
- Apr 17 – Apr 25, 2023
- Investigator
- Wayne D. McGrath
- Observations
- 3
- Pages
- 3
- FEI number
- 3002320821
In short: On April 25, 2023, FDA issued a Form 483 with 3 observations to THYMOORGAN GMBH PHARMAZIE in Vienenburg, Lower Saxony (FEI 3002320821) after an inspection that ran Apr 17 – Apr 25, 2023. The investigator was Wayne D. McGrath. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Aseptic processing areas are deficient regarding the system for monitoring…
- 03
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmTHYMOORGAN GMBH PHARMAZIE history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at THYMOORGAN GMBH PHARMAZIE?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected THYMOORGAN GMBH PHARMAZIE?
Wayne D. McGrath is named on this Form 483, for the inspection of Apr 17 – Apr 25, 2023. Each investigator has a profile showing what they cite most.
When was THYMOORGAN GMBH PHARMAZIE inspected by FDA?
The inspection ran Apr 17 – Apr 25, 2023, and the Form 483 is dated April 25, 2023.
How do I get the full Form 483 for THYMOORGAN GMBH PHARMAZIE?
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