The Procter & Gamble Manufacturing Company
Form 483 issued November 17, 2017 · Greensboro, North Carolina
- Observations
- 4
- Pages
- 6
- FEI number
- 1017175
In short: On November 17, 2017, FDA issued a Form 483 with 4 observations to The Procter & Gamble Manufacturing Company in Greensboro, North Carolina (FEI 1017175). Most observations concern production and materials.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Questions about this 483
What did FDA find at The Procter & Gamble Manufacturing Company?
FDA listed 4 observations on this Form 483, mostly about production, materials 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 November 17, 2017.
How do I get the full Form 483 for The Procter & Gamble Manufacturing Company?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.