SPERLING Inc
⚠️ Moderate Risk
FEI: 3002319564 • New York, NY • UNITED STATES
FEI Number
3002319564
Location
New York, NY
Country
UNITED STATESAddress
UNKNOWN, , New York, NY, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2014 | 64LBJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 8/7/2007 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 5/1/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/1/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/4/2002 | 66BIY99STIMULANT N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/4/2002 | 66BIY99STIMULANT N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is SPERLING Inc's FDA import refusal history?
SPERLING Inc (FEI: 3002319564) has 6 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 2/27/2014.
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. SPERLING Inc's FEI number is 3002319564.
What types of violations has SPERLING Inc received?
SPERLING Inc has been cited for 2 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 SPERLING Inc come from?
All FDA import refusal data for SPERLING Inc 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.