FDA Intel

SLOPE.IO, INC

Form 483 issued April 18, 2024 · Glen Allen, Virginia

Inspection
Apr 15 – Apr 18, 2024
Investigator
Tiki Dixon
Observations
7
Pages
6
FEI number
3018167852

In short: On April 18, 2024, FDA issued a Form 483 with 7 observations to SLOPE.IO, INC in Glen Allen, Virginia (FEI 3018167852) after an inspection that ran Apr 15 – Apr 18, 2024. The investigator was Tiki Dixon. Most observations concern production & process controls and cAPA.

At a glance

Production & process controls and capa account for 5 of 7 observations.

Production & process controls3
CAPA2
Management controls2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.70(c)

    Procedures to control environmental conditions…

  2. 02
    21 CFR 820.198(a)

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

  3. 03
    21 CFR 820.90(a)

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

  4. 04
    21 CFR 820.75(b)

    Procedures for monitoring and control of process parameters for a validated process have…

3 more observations

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

Get the full 483

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

SLOPE.IO, INC history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.70(c)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at SLOPE.IO, INC?

FDA listed 7 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 SLOPE.IO, INC?

Tiki Dixon is named on this Form 483, for the inspection of Apr 15 – Apr 18, 2024. Each investigator has a profile showing what they cite most.

When was SLOPE.IO, INC inspected by FDA?

The inspection ran Apr 15 – Apr 18, 2024, and the Form 483 is dated April 18, 2024.

How do I get the full Form 483 for SLOPE.IO, INC?

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