Innogenix, LLC
Form 483 issued November 15, 2024 · Amityville, New York
- Inspection
- Nov 6 – Nov 15, 2024
- Investigators
- Bijoy Panicker· Emmanuel T. Donyina
- Observations
- 5
- Pages
- 7
- FEI number
- 3013326213
In short: On November 15, 2024, FDA issued a Form 483 with 5 observations to Innogenix, LLC in Amityville, New York (FEI 3013326213) after an inspection that ran Nov 6 – Nov 15, 2024. The investigators were Bijoy Panicker and Emmanuel T. Donyina. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Backup data is not assured as complete and secure from alteration, erasure or loss through keeping…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmInnogenix, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innogenix, LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Innogenix, LLC?
Bijoy Panicker and Emmanuel T. Donyina are named on this Form 483, for the inspection of Nov 6 – Nov 15, 2024. Each investigator has a profile showing what they cite most.
When was Innogenix, LLC inspected by FDA?
The inspection ran Nov 6 – Nov 15, 2024, and the Form 483 is dated November 15, 2024.
How do I get the full Form 483 for Innogenix, 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.