Nordmark Pharma GmbH
Form 483 issued February 17, 2017 · Uetersen, Germany
- Investigator
- Lucila B. Nwatu
- Observations
- 3
- Pages
- 3
- FEI number
- 3003293533
In short: On February 17, 2017, FDA issued a Form 483 with 3 observations to Nordmark Pharma GmbH in Uetersen, Schleswig-Holstein (FEI 3003293533). The investigator was Lucila B. Nwatu. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Schedules and procedure are not established and maintained for all equipment to prevent malfunctions that would…
- 02
Electronic records are used that do not meet systems validation requirement to ensure that they are…
- 03
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Lucila B. Nwatu
18 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nordmark Pharma GmbH?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Nordmark Pharma GmbH?
Lucila B. Nwatu 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 February 17, 2017.
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.