Swiss-American CDMO, LLC
Form 483 issued December 16, 2024 · Carrollton, Texas
- Inspection
- Dec 9 – Dec 16, 2024
- Investigator
- Elizabeth A. Krolczyk
- Observations
- 2
- Pages
- 4
- FEI number
- 3001451826
In short: On December 16, 2024, FDA issued a Form 483 with 2 observations to Swiss-American CDMO, LLC in Carrollton, Texas (FEI 3001451826) after an inspection that ran Dec 9 – Dec 16, 2024. The investigator was Elizabeth A. Krolczyk. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.90(a) (1×) · 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been established to control product that does not…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Elizabeth A. Krolczyk
6 documents · 2024–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmSwiss-American CDMO, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Swiss-American CDMO, LLC?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Swiss-American CDMO, LLC?
Elizabeth A. Krolczyk is named on this Form 483, for the inspection of Dec 9 – Dec 16, 2024. Each investigator has a profile showing what they cite most.
When was Swiss-American CDMO, LLC inspected by FDA?
The inspection ran Dec 9 – Dec 16, 2024, and the Form 483 is dated December 16, 2024.
How do I get the full Form 483 for Swiss-American CDMO, LLC?
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.