PR Personal Care Laboratories

Form 483 issued January 29, 2024 · Valencia, California

Inspection
Jan 24 – Jan 29, 2024
Observations
3
Pages
4
FEI number
3012112573

In short: On January 29, 2024, FDA issued a Form 483 with 3 observations to PR Personal Care Laboratories in Valencia, California (FEI 3012112573) after an inspection that ran Jan 24 – Jan 29, 2024. Most observations concern cAPA and production & process controls.

At a glance

2 of 3 observations on this 483 concern capa.

CAPA2
Production & process controls1

What FDA observed

Preview: the opening words of each observation
  1. 01

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

  2. 02

    Procedures that define the responsibility for review and the authority for the disposition of nonconforming product…

  3. 03

    Schedules for the adjustment, cleaning, and other maintenance of equipment have…

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at PR Personal Care Laboratories?

FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.

When was PR Personal Care Laboratories inspected by FDA?

The inspection ran Jan 24 – Jan 29, 2024, and the Form 483 is dated January 29, 2024.

How do I get the full Form 483 for PR Personal Care Laboratories?

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