North American Custom Laboratories, LLC
Form 483 issued March 10, 2022 · Richardson, Texas
- Inspection
- Mar 1 – Mar 10, 2022
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 8
- Pages
- 7
- FEI number
- 3014229024
In short: On March 10, 2022, FDA issued a Form 483 with 8 observations to North American Custom Laboratories, LLC in Richardson, Texas (FEI 3014229024) after an inspection that ran Mar 1 – Mar 10, 2022. The investigator was Patty P. Kaewussdangkul. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: FDCA 501(a)(2)(A) (6×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
The b) <4 intended to render final product sterile…
- 02FDCA 501(a)(2)(A)
Materials or supplies were not disinfected prior to entering…
- 03FDCA 501(a)(2)(A)
Non-sterilized equipment was used…
- 04FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmNorth American Custom Laboratories, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at North American Custom Laboratories, LLC?
FDA listed 8 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected North American Custom Laboratories, LLC?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Mar 1 – Mar 10, 2022. Each investigator has a profile showing what they cite most.
When was North American Custom Laboratories, LLC inspected by FDA?
The inspection ran Mar 1 – Mar 10, 2022, and the Form 483 is dated March 10, 2022.
How do I get the full Form 483 for North American Custom Laboratories, 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.