The Procter & Gamble Manufacturing Company
⚠️ Moderate Risk
FEI: 1017175 • Greensboro, NC • UNITED STATES
FEI Number
1017175
Location
Greensboro, NC
Country
UNITED STATESAddress
100 S Swing Rd, , Greensboro, NC, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/20/2019 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Northern Border Imports (DNBI) | |
| 6/20/2019 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Northern Border Imports (DNBI) | |
| 6/20/2019 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Northern Border Imports (DNBI) | |
| 7/25/2016 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/25/2016 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/18/2015 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 11/18/2015 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/2/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 8/2/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 12/3/2004 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 5/17/2004 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 1/26/2004 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 6/25/2003 | 63SBJ99DENTAL PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 6/25/2003 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 6/25/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 5/30/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/8/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 1/30/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 1/30/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 1/7/2003 | 63RAL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 1/7/2003 | 63RAL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 12/30/2002 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 8/30/2002 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 8/16/2002 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New York District Office (NYK-DO) |
Frequently Asked Questions
What is The Procter & Gamble Manufacturing Company's FDA import refusal history?
The Procter & Gamble Manufacturing Company (FEI: 1017175) has 25 FDA import refusal record(s) in our database, spanning from 8/16/2002 to 6/20/2019.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. The Procter & Gamble Manufacturing Company's FEI number is 1017175.
What types of violations has The Procter & Gamble Manufacturing Company received?
The Procter & Gamble Manufacturing Company has been cited for 12 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about The Procter & Gamble Manufacturing Company come from?
All FDA import refusal data for The Procter & Gamble Manufacturing Company is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.