FDA Intel

Icrco, Inc

Form 483 issued September 15, 2016 · Goleta, California

Inspection
Sep 7 – Sep 15, 2016
Investigator
Sarah A. Hassas
Observations
4
Pages
2
FEI number
3009717300

In short: On September 15, 2016, FDA issued a Form 483 with 4 observations to Icrco, Inc in Goleta, California (FEI 3009717300) after an inspection that ran Sep 7 – Sep 15, 2016. The investigator was Sarah A. Hassas. Most observations concern production & process controls and cAPA.

At a glance

Production & process controls and capa account for 3 of 4 observations.

Production & process controls2
CAPA1
Records & documents1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.198(a)

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

  2. 02
    21 CFR 820.70(a)

    Process control procedures that describe any process controls necessary to ensure conformance to specifications have…

  3. 03
    21 CFR 820.184

    Procedures for device history records…

  4. 04
    21 CFR 820.120

    Procedures to control labeling activities 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 investigator

Sarah A. Hassas

5 documents · 2015–2026

Cites ISO 13485:2016 Clause 7.3.10 (definitions) more than any other section. Most of their documents are for sites in California.

The firm

Icrco, Inc history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.198(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Icrco, Inc?

FDA listed 4 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.

Who inspected Icrco, Inc?

Sarah A. Hassas is named on this Form 483, for the inspection of Sep 7 – Sep 15, 2016. Each investigator has a profile showing what they cite most.

When was Icrco, Inc inspected by FDA?

The inspection ran Sep 7 – Sep 15, 2016, and the Form 483 is dated September 15, 2016.

How do I get the full Form 483 for Icrco, Inc?

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