The Procter & Gamble Manufacturing Company

Form 483 issued February 18, 2022 · Browns Summit, North Carolina

Observations
3
Pages
5
FEI number
1033800

In short: On February 18, 2022, FDA issued a Form 483 with 3 observations to The Procter & Gamble Manufacturing Company in Browns Summit, North Carolina (FEI 1033800). Most observations concern production and facilities & equipment.

At a glance

Production and facilities & equipment account for 2 of 3 observations.

Production1
Facilities & equipment1
Quality system1

What FDA observed

Preview: the opening words of each observation
  1. 01

    Control procedures are not established which validate the performance of those manufacturing processes that may be…

  2. 02

    Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…

  3. 03

    Investigations of an unexplained discrepancy and a failure of a batch or any of its components…

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 The Procter & Gamble Manufacturing Company?

FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.

When was The Procter & Gamble Manufacturing Company inspected by FDA?

This Form 483 is dated February 18, 2022.

How do I get the full Form 483 for The Procter & Gamble Manufacturing Company?

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