Serumwerk Bernburg AG
Form 483 issued June 14, 2024 · Bernburg, Germany
- Inspection
- Jun 10 – Jun 14, 2024
- Investigator
- David A. Oluwo
- Observations
- 2
- Pages
- 3
- FEI number
- 3003903447
In short: On June 14, 2024, FDA issued a Form 483 with 2 observations to Serumwerk Bernburg AG in Bernburg, Germany (FEI 3003903447) after an inspection that ran Jun 10 – Jun 14, 2024. The investigator was David A. Oluwo. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of an active…
- 02
Written specifications for laboratory…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmSerumwerk Bernburg AG 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 Serumwerk Bernburg AG?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Serumwerk Bernburg AG?
David A. Oluwo is named on this Form 483, for the inspection of Jun 10 – Jun 14, 2024. Each investigator has a profile showing what they cite most.
When was Serumwerk Bernburg AG inspected by FDA?
The inspection ran Jun 10 – Jun 14, 2024, and the Form 483 is dated June 14, 2024.
How do I get the full Form 483 for Serumwerk Bernburg AG?
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.