FDA Intel

Swiss-American CDMO, LLC

Form 483 issued December 19, 2022 · Carrollton, Texas

Inspection
Dec 13 – Dec 19, 2022
Observations
4
Pages
5
FEI number
3001451826

In short: On December 19, 2022, FDA issued a Form 483 with 4 observations to Swiss-American CDMO, LLC in Carrollton, Texas (FEI 3001451826) after an inspection that ran Dec 13 – Dec 19, 2022. Most observations concern production & process controls and cAPA.

At a glance

3 of 4 observations on this 483 concern production & process controls.

Production & process controls3
CAPA1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.70(i)

    Software used as part of the quality system has not been adequately validated for its intended…

  2. 02
    21 CFR 820.75(a)

    A process whose results cannot be fully verified by subsequent inspection and test has not been…

  3. 03
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

  4. 04
    21 CFR 820.50(a)(3)

    Records of acceptable suppliers have…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The firm

Swiss-American CDMO, LLC history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other 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 4 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.

When was Swiss-American CDMO, LLC inspected by FDA?

The inspection ran Dec 13 – Dec 19, 2022, and the Form 483 is dated December 19, 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.

$99Get it free