Advanced Nutriceuticals, LLC
Form 483 issued November 22, 2024 · Indianapolis, Indiana
- Inspection
- Nov 13 – Nov 15, 2024
- Investigator
- Taichun Qin
- Observations
- 10
- Pages
- 6
- FEI number
- 3010039017
In short: On November 22, 2024, FDA issued a Form 483 with 10 observations to Advanced Nutriceuticals, LLC in Indianapolis, Indiana (FEI 3010039017) after an inspection that ran Nov 13 – Nov 15, 2024. The investigator was Taichun Qin.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
- 02FDCA 501(a)(2)(A)
The ISO 5 classified area is located…
- 03FDCA 501(a)(2)(A)
Vermin or other animals or evidence of their presence was observed in the areas…
- 04FDCA 501(a)(2)(A)
Use of a sporicidal agent in…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmAdvanced Nutriceuticals, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Advanced Nutriceuticals, LLC?
FDA listed 10 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Advanced Nutriceuticals, LLC?
Taichun Qin is named on this Form 483, for the inspection of Nov 13 – Nov 15, 2024. Each investigator has a profile showing what they cite most.
When was Advanced Nutriceuticals, LLC inspected by FDA?
The inspection ran Nov 13 – Nov 15, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Advanced Nutriceuticals, 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.