Nordmark Pharma GmbH
Form 483 issued August 16, 2019 · Uetersen, Germany
- Investigator
- Charles L. Zhou
- Observations
- 2
- Pages
- 1
- FEI number
- 3003293533
In short: On August 16, 2019, FDA issued a Form 483 with 2 observations to Nordmark Pharma GmbH in Uetersen, Schleswig-Holstein (FEI 3003293533). The investigator was Charles L. Zhou. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 2 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 exercise sufficient controls over computerized systems to prevent unauthorized access…
- 02
Failure to adequately investigate or document investigations…
This inspection in context
Charles L. Zhou
11 documents · 2016–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmNordmark Pharma GmbH history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nordmark Pharma GmbH?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Nordmark Pharma GmbH?
Charles L. Zhou is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Nordmark Pharma GmbH inspected by FDA?
This Form 483 is dated August 16, 2019.
How do I get the full Form 483 for Nordmark Pharma 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.