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Form 483 · FEI 3018078670

Form 483 issued November 6, 2024 · Washington, District of Columbia

Inspection
Nov 4 – Nov 6, 2024
Investigator
Tiki Dixon
Observations
4
Pages
4
FEI number
3018078670

In short: On November 6, 2024, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Washington, District of Columbia (FEI 3018078670) after an inspection that ran Nov 4 – Nov 6, 2024. The investigator was Tiki Dixon. Most observations concern production & process controls and management controls.

At a glance

Production & process controls and management controls account for 4 of 4 observations.

Production & process controls2
Management controls2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.80(a)

    Procedures for acceptance activities have…

  2. 02
    21 CFR 820.70(i)

    Software used as part of production and the quality system has not been adequately validated for…

  3. 03
    21 CFR 820.20(c)

    Procedures for management review have…

  4. 04
    21 CFR 820.22

    Procedures for quality audits 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

Tiki Dixon

10 documents · 2016–2024

Cites 820.80(a) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in Virginia.

The firm

Site history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.80(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at an FDA-inspected site?

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

Who inspected an FDA-inspected site?

Tiki Dixon is named on this Form 483, for the inspection of Nov 4 – Nov 6, 2024. Each investigator has a profile showing what they cite most.

When was an FDA-inspected site inspected by FDA?

The inspection ran Nov 4 – Nov 6, 2024, and the Form 483 is dated November 6, 2024.

How do I get the full Form 483 for an FDA-inspected site?

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