Form 483 · FEI 3008587095
Form 483 issued July 12, 2019 · Gottingen, Germany
- Inspection
- Jul 8 – Jul 12, 2019
- Investigator
- Christopher R. Czajka
- Observations
- 7
- Pages
- 4
- FEI number
- 3008587095
In short: On July 12, 2019, FDA issued a Form 483 with 7 observations to an FDA-inspected site in Gottingen, Niedersachsen (FEI 3008587095) after an inspection that ran Jul 8 – Jul 12, 2019. The investigator was Christopher R. Czajka. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The batch production and control records are deficient in that they do not include weights of…
- 02
Laboratory records do not include the initials or signature of a second person showing that the…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Christopher R. Czajka is named on this Form 483, for the inspection of Jul 8 – Jul 12, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 8 – Jul 12, 2019, and the Form 483 is dated July 12, 2019.
How do I get the full Form 483 for an FDA-inspected site?
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.