The Procter & Gamble Manufacturing Company
Form 483 issued March 10, 2023 · Greensboro, North Carolina
- Investigator
- Harshal J. Desai
- Observations
- 2
- Pages
- 3
- FEI number
- 1017175
In short: On March 10, 2023, FDA issued a Form 483 with 2 observations to The Procter & Gamble Manufacturing Company in Greensboro, North Carolina (FEI 1017175). The investigator was Harshal J. Desai. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and production account for 2 of 2 observations.
Most cited: 21 CFR 211.84(b) (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Representative samples are not taken of each shipment of each lot of components…
- 02
Written production and process control procedures are not documented at…
This inspection in context
Harshal J. Desai
6 documents · 2022–2024
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmThe Procter & Gamble Manufacturing Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Procter & Gamble Manufacturing Company?
FDA listed 2 observations on this Form 483, mostly about materials and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected The Procter & Gamble Manufacturing Company?
Harshal J. Desai is named on this Form 483. Each investigator has a profile showing what they cite most.
When was The Procter & Gamble Manufacturing Company inspected by FDA?
This Form 483 is dated March 10, 2023.
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.