FDA Intel

RetroPerc, Inc

Form 483 issued December 18, 2024 · Jersey City, New Jersey

Inspection
Dec 11 – Dec 18, 2024
Investigator
Colin E. Tack
Observations
6
Pages
7
FEI number
3019946783

In short: On December 18, 2024, FDA issued a Form 483 with 6 observations to RetroPerc, Inc in Jersey City, New Jersey (FEI 3019946783) after an inspection that ran Dec 11 – Dec 18, 2024. The investigator was Colin E. Tack. Most observations concern management controls and design controls.

At a glance

Management controls and design controls account for 4 of 6 observations.

Management controls3
Design controls1
Production & process controls1
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.30(a)

    Procedures for design control…

  2. 02
    21 CFR 820.50

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

  3. 03
    21 CFR 820.20(c)

    Management with executive responsibility has not reviewed the suitability and effectiveness of the quality…

  4. 04
    21 CFR 820.22

    Procedures for quality audits have…

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

Colin E. Tack

8 documents · 2019–2026

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

The firm

RetroPerc, Inc history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.30(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at RetroPerc, Inc?

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

Who inspected RetroPerc, Inc?

Colin E. Tack is named on this Form 483, for the inspection of Dec 11 – Dec 18, 2024. Each investigator has a profile showing what they cite most.

When was RetroPerc, Inc inspected by FDA?

The inspection ran Dec 11 – Dec 18, 2024, and the Form 483 is dated December 18, 2024.

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

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