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The Procter & Gamble Manufacturing Company FDA Inspection Record

FEI 1017175 · Inspections, Form 483s, warning letters and import refusals

The Procter & Gamble Manufacturing Company is an FDA-inspected facility (FEI 1017175) located in Greensboro, NC, US. RegDataLab tracks 7 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 9, 2026: Official Action Indicated (OAI)
Inspections on record
7 (1 OAI, 4 VAI, 2 NAI)
Last OAI inspection
Jun 9, 2026
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Aug 18, 2004
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jun 9, 2026Official Action Indicated (OAI)Written program not followed (21 CFR 211.166(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Description and Identification of Samples (21 CFR 211.194(a)(1))
Reprocessing procedures lack steps to be taken (21 CFR 211.115(a))
Mar 10, 2023Voluntary Action Indicated (VAI)SOPs not followed / documented (21 CFR 211.100(b))
Representative Samples (21 CFR 211.84(b))
Nov 17, 2017Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Testing and release for distribution (21 CFR 211.165(a))
Complaint Handling Procedure (21 CFR 211.198(a))
Control procedures to monitor and validate performance (21 CFR 211.110(a))
May 6, 2016No Action Indicated (NAI)No citations listed
Jul 18, 2013Voluntary Action Indicated (VAI)Laboratory equipment calibration records (21 CFR 211.194(d))
Feb 5, 2010Voluntary Action Indicated (VAI)SOPs not followed / documented (21 CFR 211.100(b))
Sep 24, 2009No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Aug 18, 2004Class IIID-269-4Non Drowsy Vicks Formula 44 Cough Relief, 4 fl oz.(118mL), Dist. by Proctor and Gamble…
Shelf cartons labeled as Vicks Formula 44 Cough Relief may contain bottles of Vicks Formula 44, Multi-Symptom Relief.

Facility details

Company
The Procter & Gamble Manufacturing Company
Location
Greensboro, NC (US)
Source
inspections

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.