Swiss-American CDMO, LLC
Form 483 issued September 28, 2018 · Carrollton, Texas
- Inspection
- Sep 26 – Sep 28, 2018
- Investigator
- Jude C. Dike
- Observations
- 1
- Pages
- 3
- FEI number
- 3001451826
In short: On September 28, 2018, FDA issued a Form 483 with 1 observation to Swiss-American CDMO, LLC in Carrollton, Texas (FEI 3001451826) after an inspection that ran Sep 26 – Sep 28, 2018. The investigator was Jude C. Dike. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Software used as part of the quality system has not been adequately validated for its intended…
This inspection in context
Jude C. Dike
9 documents · 2015–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
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 820.70(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Swiss-American CDMO, LLC?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Swiss-American CDMO, LLC?
Jude C. Dike is named on this Form 483, for the inspection of Sep 26 – Sep 28, 2018. Each investigator has a profile showing what they cite most.
When was Swiss-American CDMO, LLC inspected by FDA?
The inspection ran Sep 26 – Sep 28, 2018, and the Form 483 is dated September 28, 2018.
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.