Advanced Nutriceuticals, LLC
Form 483 issued October 29, 2020 · Indianapolis, Indiana
- Inspection
- Oct 13 – Oct 29, 2020
- Investigators
- Bei Y. He· Jon P. Antoniou
- Observations
- 13
- Pages
- 17
- FEI number
- 3010039017
In short: On October 29, 2020, FDA issued a Form 483 with 13 observations to Advanced Nutriceuticals, LLC in Indianapolis, Indiana (FEI 3010039017) after an inspection that ran Oct 13 – Oct 29, 2020. The investigators were Bei Y. He and Jon P. Antoniou. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
8 of 13 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (8×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You performed aseptic processing outside of a…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Your employees touched equipment and other surface areas outside the ISO 5 area with gloved hands…
- 04
Your sterile technician moved rapidly in the vicinity of open…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmAdvanced Nutriceuticals, 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 Advanced Nutriceuticals, LLC?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and materials. 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 Advanced Nutriceuticals, LLC?
Bei Y. He and Jon P. Antoniou are named on this Form 483, for the inspection of Oct 13 – Oct 29, 2020. Each investigator has a profile showing what they cite most.
When was Advanced Nutriceuticals, LLC inspected by FDA?
The inspection ran Oct 13 – Oct 29, 2020, and the Form 483 is dated October 29, 2020.
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.