Reckitt Benckiser Pakistan Ltd.
⚠️ Moderate Risk
FEI: 3004524689 • Karachi • PAKISTAN
FEI Number
3004524689
Location
Karachi
Country
PAKISTANAddress
F-18 S.i.t.e., , Karachi, , Pakistan
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
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).
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.
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).
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.
NOCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2021 | 64AAL99DISINFECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/19/2021 | 64AAL99DISINFECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/14/2009 | 61FAK21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 5/14/2009 | 61FAK21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) | |
| 6/21/2004 | 61FBY21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Reckitt Benckiser Pakistan Ltd.'s FDA import refusal history?
Reckitt Benckiser Pakistan Ltd. (FEI: 3004524689) has 5 FDA import refusal record(s) in our database, spanning from 6/21/2004 to 2/19/2021.
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. Reckitt Benckiser Pakistan Ltd.'s FEI number is 3004524689.
What types of violations has Reckitt Benckiser Pakistan Ltd. received?
Reckitt Benckiser Pakistan Ltd. has been cited for 8 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 Reckitt Benckiser Pakistan Ltd. come from?
All FDA import refusal data for Reckitt Benckiser Pakistan Ltd. 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.