ASC Marketing LTD
Form 483 issued April 5, 2024 · Chula Vista, California
- Inspection
- Apr 2 – Apr 5, 2024
- Investigators
- Nicholas L. Hunt· Rachel C. Stanton
- Observations
- 2
- Pages
- 4
- FEI number
- 3015417758
In short: On April 5, 2024, FDA issued a Form 483 with 2 observations to ASC Marketing LTD in Chula Vista, California (FEI 3015417758) after an inspection that ran Apr 2 – Apr 5, 2024. The investigators were Nicholas L. Hunt and Rachel C. Stanton. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(a) (1×) · 211.165(f) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Drug products failing to meet established quality control…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmASC Marketing LTD history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ASC Marketing LTD?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected ASC Marketing LTD?
Nicholas L. Hunt and Rachel C. Stanton are named on this Form 483, for the inspection of Apr 2 – Apr 5, 2024. Each investigator has a profile showing what they cite most.
When was ASC Marketing LTD inspected by FDA?
The inspection ran Apr 2 – Apr 5, 2024, and the Form 483 is dated April 5, 2024.
How do I get the full Form 483 for ASC Marketing LTD?
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.