Swiss-American CDMO, LLC
Form 483 issued September 4, 2008 · Carrollton, Texas
- Inspection
- Aug 12 – Sep 4, 2008
- Investigator
- Margaret M. Annes
- Observations
- 15
- Pages
- 7
- FEI number
- 3001451826
In short: On September 4, 2008, FDA issued a Form 483 with 15 observations to Swiss-American CDMO, LLC in Carrollton, Texas (FEI 3001451826) after an inspection that ran Aug 12 – Sep 4, 2008. The investigator was Margaret M. Annes. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 10 of 15 observations.
Most cited: 21 CFR 820.30 (7×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to control the design process of the…
- 02
A design and development plan…
- 03
The design history file…
- 04
Design input requirements were…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) 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 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Swiss-American CDMO, LLC?
FDA listed 15 observations on this Form 483, mostly about design controls, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Swiss-American CDMO, LLC?
Margaret M. Annes is named on this Form 483, for the inspection of Aug 12 – Sep 4, 2008. Each investigator has a profile showing what they cite most.
When was Swiss-American CDMO, LLC inspected by FDA?
The inspection ran Aug 12 – Sep 4, 2008, and the Form 483 is dated September 4, 2008.
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.