Key facts
| Firm | Advanced Nutriceuticals, LLC |
|---|---|
| FEI / inspection ID | 3010039017 |
| Inspection end date | November 22, 2024 |
| Citation count | 5 |
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
Citations explained
Observation 1 — Failure to conduct media fills that closely simulate aseptic production operations un
Failure to conduct media fills that closely simulate aseptic production operations un de r the worst-case, most-challenging, and stressful conditions. Specifically, The media fill process does not simulate aseptic processing under wo rst-case conditions. The technicians and phann ac ist invo lved in sterile process in~h ave peifo1med media fills using a (6) (-4 ) J "!141. This invo lves aseptically transfeITin g 6J from [( 6 ) (-4 ) Ivial sets into a {D} {4 ~ sten le vial, with 'b) (~) I vials filled with media fo r incubation. The cmTent media fill simulates the preparation of a s in~e intravenous (IV) bag; however, technicians produce up to 6f<-l~InIV b1ags [(b (4) l, averaging ~ IV bags per day, with a maximum of ~6J ~ IV bags in (6) (4 ) . For example, on 1 1/ 13/ 2024, 4 it was observed that technician i~i prepared a total of ( l:>)( IV bags (with a BUD)~ f.
Observation 2 — The ISO 5 classified area is located within a no n- classified
The ISO 5 classified area is located within a no n- classified room. Specifically, The ISO 5 LAFH, Equipment ID 132224, used for mixing sterile vials into IV bags fo r infusion, is located within an unclassified room. The most recent [(6 ) (~) I ce1t ification of the ISO 5 LAFH, EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Taichun Qin, Investigator 11 /22/2024 OF THIS PAGE T.....,a,, 08;3i.1 ~20013'A646 11-22·2024 X FORM FDA ~83 (09/ 08) PAGE I of5 PAGES PREVIOUS EDmON OBSOL!m! INS PEC TIONAL OBSERVATIONS
Observation 3 — Ve1min or other animals or evidence of their presence was observed in
Ve1min or other animals or evidence of their presence was observed in the areas adjacent to production areas. Specifica lly, On 11/13/2024, during the compounding of Estradiol (Lot# 11- 13 -2024L, 600 capsules, BUD: 5/12/2025), the following observations were made: A.Dead Insects in Biological Safety Cabinets ~B SCs): Dead mosquitoes and other uni de ntified insects were observed on the isolated top layer o ~bl{4 Bio logical Safety Cabinets (BSCs), Equipment IDs oc.o> (4> !where exhausted air passes through. Although these insects were not in the airect proauct processmg area, their presence on the BSC exhaust layer indicates that contaminan ts may have ever entered the processing area, which maintains negative pressure relative to the surrounding environment and then exhausted. It remains unclear when and how these insects entered the BSCs, which are located in a segregated and enclosed suite. The fnm has been compounding hazardous diugs in this newly constrncted hazardous facility since 04/2023, producing approximately 6>l4 batches per.
Observation 4 — Use of a sporicidal agent in the facility's was infrequent
Use of a sporicidal agent in the facility's was infrequent. EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Taichun Qin, I nves ti ga t or 11 /22/2024 OF THIS PAGE T.....,a,, ~~~~200 s~ 13'A646 X 1 1-22..2024 08:32>1 FORM FDA ~83 (09/ 08) N PAGE2 of5 AGES PREVIOUS EDmON OBSOL!m! INSPECTIO AL O BSERVATIONS P -- 2 of 6 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D I STRI CT ADDRESS ANO P HONE NUMBER OATE(S) OF INSPECTION 300 River P lace, Sui te 5900 ll / 1 3/202 4 - 11 /22/202 4* De tr oi t, MI 4 8207 FEJNUMBER 30 1 00390 1 7 (313) 393 - 8 1 00 Fax: (3 1 3)393 - 8 1 39 NAME AND T ITLE OF INDIVIDUAL TO WHOM REPORT ISSUED Collin M. Baker, P ha r macis t F IRM NAME STRE
Observation 5 — Materials were exposed to lower than ISO 5 quality air
Materials were exposed to lower than ISO 5 quality air. Specifically, On 11/13/2024 and 11/14/2024, sterile wipes were observed left open in an unclassified area on a caii near the ISO 5 LAFH. Phaim acist P9 stated that these wipes wou ld be used to clean the ISO 5 LA FH if mop wipers were unavailable. *DATES OF INSPECTION 11/13/2024(Wed), l l/ 14/2024(Thu), 11/15/2024(Fri), l l/l 8/2024(Mon), l l /l 9/2024(Tue), l l /20/2024(Wed), l l/2 l/2024(Thu), l l/22/2024(Fr i) SEE REVERSE OF THIS PAGE
Advanced Nutriceuticals, LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Advanced Nutriceuticals, LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
- Does this Form 483 mean Advanced Nutriceuticals, LLC violated the law?
- No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Advanced Nutriceuticals, LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Advanced Nutriceuticals, LLC so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for Advanced Nutriceuticals, LLCCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2024). Advanced Nutriceuticals, LLC — FDA Form 483 Inspection, November 22, 2024 (5 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-advanced-nutriceuticals-llc-2024-11-22-3010039017
"Advanced Nutriceuticals, LLC — FDA Form 483 Inspection, November 22, 2024 (5 Citations)." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-advanced-nutriceuticals-llc-2024-11-22-3010039017.
Argus HQ Research. "Advanced Nutriceuticals, LLC — FDA Form 483 Inspection, November 22, 2024 (5 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-advanced-nutriceuticals-llc-2024-11-22-3010039017.
@misc{argushq_argushq_ai_483_fda_483_advanced_nutriceuticals_llc_2024_11_22_3010039017_2024,
title = {Advanced Nutriceuticals, LLC — FDA Form 483 Inspection, November 22, 2024 (5 Citations)},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-advanced-nutriceuticals-llc-2024-11-22-3010039017},
note = {Accessed: July 13, 2026}
}