Swiss-American CDMO, LLC
Form 483 issued March 31, 2022 · Carrollton, Texas
- Inspection
- Mar 22 – Mar 31, 2022
- Investigators
- Jessica M. Simpson· Patty P. Kaewussdangkul· Shanna N. Purdy
- Observations
- 8
- Pages
- 7
- FEI number
- 3001451826
In short: On March 31, 2022, FDA issued a Form 483 with 8 observations to Swiss-American CDMO, LLC in Carrollton, Texas (FEI 3001451826) after an inspection that ran Mar 22 – Mar 31, 2022. The investigators were Jessica M. Simpson, Patty P. Kaewussdangkul and Shanna N. Purdy. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
GMP training is not conducted on a continuing basis to assure that employees remain familiar with…
This inspection in context
Jessica M. Simpson
4 documents · 2022–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Swiss-American CDMO, LLC?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Swiss-American CDMO, LLC?
Jessica M. Simpson, Patty P. Kaewussdangkul and Shanna N. Purdy are named on this Form 483, for the inspection of Mar 22 – Mar 31, 2022. Each investigator has a profile showing what they cite most.
When was Swiss-American CDMO, LLC inspected by FDA?
The inspection ran Mar 22 – Mar 31, 2022, and the Form 483 is dated March 31, 2022.
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.