FDA Intel

Hatch Product Development LLC

Form 483 issued December 11, 2025 · Waukegan, Illinois

Inspection
Dec 8 – Dec 11, 2025
Observations
5
Pages
5
FEI number
3030438338

In short: On December 11, 2025, FDA issued a Form 483 with 5 observations to Hatch Product Development LLC in Waukegan, Illinois (FEI 3030438338) after an inspection that ran Dec 8 – Dec 11, 2025. Most observations concern cAPA and production & process controls.

At a glance

4 of 5 observations on this 483 concern capa.

CAPA4
Production & process controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

  2. 02
    21 CFR 820.198(a)

    Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…

  3. 03
    21 CFR 803.17

    Written MDR procedures have not been…

  4. 04
    21 CFR 820.90(a)

    Procedures have not been adequately established to control product that does not…

1 more observation

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

Get the full 483

This inspection in context

The firm

Hatch Product Development LLC history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.100(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Hatch Product Development LLC?

FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.

When was Hatch Product Development LLC inspected by FDA?

The inspection ran Dec 8 – Dec 11, 2025, and the Form 483 is dated December 11, 2025.

How do I get the full Form 483 for Hatch Product Development LLC?

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