Advanced Nutriceuticals, LLC
FDA inspection history in Indianapolis, Indiana, 2020 to 2024
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2020: one Form 483; 2021: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–21One Form 483 and one warning letter, at Indianapolis, Indiana.
- 2024One Form 483, at Indianapolis, Indiana.
- 2024The longest 483 on file: 10 observations over 6 pages at Indianapolis, Indiana.
Cited most
Across all Advanced Nutriceuticals observations on file
- FDCA 501(a)(2)(A)Insanitary conditions10
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Advanced Nutriceuticals file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Indianapolis, Indiana
Two Form 483s, one warning letter and one close-out letter · 2020 to 2024 · 14 observations
Latest: Form 483, Nov 22, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-22 | 483 Form 483 | Indianapolis, Indiana | 10 | $99 |
| 2021-11-10 | Warning letter Warning letter | Indianapolis, Indiana | — | $99 |
| 2020-10-29 | 483 Form 483 | Indianapolis, Indiana | 4 | $99 |
| Undated | Close-out Close-out letter | Indianapolis, Indiana | — | $99 |
Investigators on these documents
FEI number 3010039017 · most recent document Nov 22, 2024
About Advanced Nutriceuticals, LLC
How many FDA Form 483s has Advanced Nutriceuticals, LLC received?
FDA Intel has 2 Form 483s on file for Advanced Nutriceuticals, LLC; the most recent is dated Nov 22, 2024.
When was Advanced Nutriceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Advanced Nutriceuticals, LLC is a Form 483 dated Nov 22, 2024, for the site in Indianapolis, Indiana.
What did FDA cite at Advanced Nutriceuticals, LLC?
The regulations cited most in the observations on file for Advanced Nutriceuticals, LLC are FDCA 501(a)(2)(A) (Insanitary conditions), 10 times; 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.42 (Design and construction features), 3 times.
Has Advanced Nutriceuticals, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Advanced Nutriceuticals, LLC; the most recent is dated Nov 10, 2021.