Grant Industries Inc.
Form 483 issued June 16, 2025 · Elmwood Park, New Jersey
- Inspection
- May 28 – Jun 16, 2025
- Investigators
- Geoffrey K. Kilili· Ucheabuchi C. Chudi-Nwankwor
- Observations
- 7
- Pages
- 28
- FEI number
- 3009862165
In short: On June 16, 2025, FDA issued a Form 483 with 7 observations to Grant Industries Inc. in Elmwood Park, New Jersey (FEI 3009862165) after an inspection that ran May 28 – Jun 16, 2025. The investigators were Geoffrey K. Kilili and Ucheabuchi C. Chudi-Nwankwor. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
The written stability program for drug products does not include reliable, meaningful…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Geoffrey K. Kilili
7 documents · 2021–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmGrant Industries Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grant Industries Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Grant Industries Inc.?
Geoffrey K. Kilili and Ucheabuchi C. Chudi-Nwankwor are named on this Form 483, for the inspection of May 28 – Jun 16, 2025. Each investigator has a profile showing what they cite most.
When was Grant Industries Inc. inspected by FDA?
The inspection ran May 28 – Jun 16, 2025, and the Form 483 is dated June 16, 2025.
How do I get the full Form 483 for Grant Industries Inc.?
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.