FDA Intel

ErgoMed, Inc

Form 483 issued October 5, 2022 · San Antonio, Texas

Inspection
Oct 3 – Oct 5, 2022
Investigator
Christine I. Shaw
Observations
6
Pages
5
FEI number
1000306115

In short: On October 5, 2022, FDA issued a Form 483 with 6 observations to ErgoMed, Inc in San Antonio, Texas (FEI 1000306115) after an inspection that ran Oct 3 – Oct 5, 2022. The investigator was Christine I. Shaw. Most observations concern production & process controls and cAPA.

At a glance

Production & process controls and capa account for 4 of 6 observations.

Production & process controls2
CAPA2
Management controls1
Records & documents1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.50

    Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…

  2. 02
    21 CFR 820.80(a)

    Procedures for acceptance activities have…

  3. 03
    21 CFR 820.90(a)

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

  4. 04
    21 CFR 803.17(a)(1)

    The written MDR Procedme does not include an internal system which provides for timely and effective…

2 more observations

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

Get the full 483

This inspection in context

The investigator

Christine I. Shaw

8 documents · 2016–2022

Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Colorado.

The firm

ErgoMed, Inc history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.50

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at ErgoMed, Inc?

FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.

Who inspected ErgoMed, Inc?

Christine I. Shaw is named on this Form 483, for the inspection of Oct 3 – Oct 5, 2022. Each investigator has a profile showing what they cite most.

When was ErgoMed, Inc inspected by FDA?

The inspection ran Oct 3 – Oct 5, 2022, and the Form 483 is dated October 5, 2022.

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

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