Kaysersberg Pharmaceuticals
Form 483 issued July 7, 2023 · Kaysersberg-Vignoble, France
- Inspection
- Jun 29 – Jul 7, 2023
- Investigator
- Lori B. Wikstrom
- Observations
- 2
- Pages
- 1
- FEI number
- 3002806288
In short: On July 7, 2023, FDA issued a Form 483 with 2 observations to Kaysersberg Pharmaceuticals in Kaysersberg-Vignoble, Haut-Rhin (FEI 3002806288) after an inspection that ran Jun 29 – Jul 7, 2023. The investigator was Lori B. Wikstrom. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.165 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity and reproducibility of test methods…
- 02
Appropriate controls shall be exercised over computer or related systems to assure that changes in master…
This inspection in context
Lori B. Wikstrom
5 documents · 2020–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
The firmKaysersberg Pharmaceuticals history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kaysersberg Pharmaceuticals?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Kaysersberg Pharmaceuticals?
Lori B. Wikstrom is named on this Form 483, for the inspection of Jun 29 – Jul 7, 2023. Each investigator has a profile showing what they cite most.
When was Kaysersberg Pharmaceuticals inspected by FDA?
The inspection ran Jun 29 – Jul 7, 2023, and the Form 483 is dated July 7, 2023.
How do I get the full Form 483 for Kaysersberg Pharmaceuticals?
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.