FDA Intel

Caragh Precision

Form 483 issued July 17, 2025

Inspection
Jul 14 – Jul 17, 2025
Observations
3
Pages
5
FEI number
3009173317

In short: On July 17, 2025, FDA issued a Form 483 with 3 observations to Caragh Precision (FEI 3009173317) after an inspection that ran Jul 14 – Jul 17, 2025. Most observations concern production & process controls and cAPA.

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
    21 CFR 820.50(a)

    Requirements that must be met by suppliers, contractors and consultants have…

  2. 02
    21 CFR 820.70(b)

    Procedures for changes to a process and procedure have…

  3. 03
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

The full 483

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

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This inspection in context

The firm

Caragh Precision history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.50(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Caragh Precision?

FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.

When was Caragh Precision inspected by FDA?

The inspection ran Jul 14 – Jul 17, 2025, and the Form 483 is dated July 17, 2025.

How do I get the full Form 483 for Caragh Precision?

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