Gemini PharmChem Mannheim GmbH
Form 483 issued January 21, 2022 · Mannheim, Germany
- Inspection
- Jan 17 – Jan 21, 2022
- Observations
- 3
- Pages
- 1
- FEI number
- 3014000756
In short: On January 21, 2022, FDA issued a Form 483 with 3 observations to Gemini PharmChem Mannheim GmbH in Mannheim, Germany (FEI 3014000756) after an inspection that ran Jan 17 – Jan 21, 2022. Most observations concern materials and quality system.
At a glance
2 of 3 observations on this 483 concern materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Secondary packaging components for API products stored…
- 02
No documentation of incoming inspection checklist…
- 03
Not all records and reports are completely filled out after signed off by responsible…
This inspection in context
Questions about this 483
What did FDA find at Gemini PharmChem Mannheim GmbH?
FDA listed 3 observations on this Form 483, mostly about materials and quality system. The opening words of each observation are shown on this page.
When was Gemini PharmChem Mannheim GmbH inspected by FDA?
The inspection ran Jan 17 – Jan 21, 2022, and the Form 483 is dated January 21, 2022.
How do I get the full Form 483 for Gemini PharmChem Mannheim 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.