Norbitec GmbH
Form 483 issued April 6, 2023 · Uetersen, Germany
- Inspection
- Mar 30 – Apr 6, 2023
- Investigators
- Nailing Zhang· Wayne Seifert
- Observations
- 4
- Pages
- 4
- FEI number
- 3010763764
In short: On April 6, 2023, FDA issued a Form 483 with 4 observations to Norbitec GmbH in Uetersen, Germany (FEI 3010763764) after an inspection that ran Mar 30 – Apr 6, 2023. The investigators were Nailing Zhang and Wayne Seifert. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You failed to conduct appropriate corrective action and preventative action and provide adequate quality oversight over…
- 02
Validations and testing in support of (b)(4) drug…
- 03
Equipment and facility systems in support of (b)(4) drug substance manufacture are not adequately maintained or…
- 04
A standard operating procedure in support of (b)(4) drug…
This inspection in context
Nailing Zhang
4 documents · 2018–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.
The firmNorbitec GmbH history
The site's inspection history, in date order.
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 Norbitec GmbH?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Norbitec GmbH?
Nailing Zhang and Wayne Seifert are named on this Form 483, for the inspection of Mar 30 – Apr 6, 2023. Each investigator has a profile showing what they cite most.
When was Norbitec GmbH inspected by FDA?
The inspection ran Mar 30 – Apr 6, 2023, and the Form 483 is dated April 6, 2023.
How do I get the full Form 483 for Norbitec 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.