J Sterling Industries, LLC

Form 483 issued January 8, 2026 · Kalamazoo, Michigan

Inspection
Jan 5 – Jan 8, 2026
Investigator
Suyang Qin
Observations
3
Pages
10
FEI number
3008879776

In short: On January 8, 2026, FDA issued a Form 483 with 3 observations to J Sterling Industries, LLC in Kalamazoo, Michigan (FEI 3008879776) after an inspection that ran Jan 5 – Jan 8, 2026. The investigator was Suyang Qin. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).

At a glance

2 of 3 observations on this 483 concern production & process controls.

Production & process controls2
CAPA1

What FDA observed

Preview: the opening words of each observation
  1. 01

    Procedures to control environmental conditions have…

  2. 02

    Procedures for corrective and preventive action have…

  3. 03

    Schedules for the adjustment, cleaning, and other maintenance of equipment have…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

Questions about this 483

What did FDA find at J Sterling Industries, LLC?

FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.

Who inspected J Sterling Industries, LLC?

Suyang Qin is named on this Form 483, for the inspection of Jan 5 – Jan 8, 2026. Each investigator has a profile showing what they cite most.

When was J Sterling Industries, LLC inspected by FDA?

The inspection ran Jan 5 – Jan 8, 2026, and the Form 483 is dated January 8, 2026.

How do I get the full Form 483 for J Sterling Industries, LLC?

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