Recipharm Pharmaservices Private Limited
⚠️ High Risk
FEI: 3009150119 • Bengaluru, Karnataka • INDIA
FEI Number
3009150119
Location
Bengaluru, Karnataka
Country
INDIAAddress
Khata No. 845/713 and 1108/970/1, 34th KM, Tumkur Road, (NH 4) Teppada Begur, Nelamangala Taluk, Bengaluru, Karnataka, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/18/2024 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/5/2024 | 61TCA29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | Division of Southeast Imports (DSEI) | |
| 11/30/2017 | 66FCL99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2014 | 56IBA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/1/2013 | 64BCB37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/1/2013 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/1/2013 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/1/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Recipharm Pharmaservices Private Limited's FDA import refusal history?
Recipharm Pharmaservices Private Limited (FEI: 3009150119) has 9 FDA import refusal record(s) in our database, spanning from 2/1/2006 to 10/18/2024.
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. Recipharm Pharmaservices Private Limited's FEI number is 3009150119.
What types of violations has Recipharm Pharmaservices Private Limited received?
Recipharm Pharmaservices Private Limited has been cited for 4 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 Recipharm Pharmaservices Private Limited come from?
All FDA import refusal data for Recipharm Pharmaservices Private Limited 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.