UNILAB CHEMICALS & PHARMACEUTICALS PVT.LTD.
⚠️ High Risk
FEI: 3004919402 • Mumbai, Maharashtra • INDIA
FEI Number
3004919402
Location
Mumbai, Maharashtra
Country
INDIAAddress
316 Anjani Complex, Perera Hill Road, Mumbai, Maharashtra, 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
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 |
|---|---|---|---|
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 61XJS06CHLORCYCLIZINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 10/26/2006 | 68DYY20FUNGICIDE USED MORE THAN 1 SPECIES | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/26/2006 | 68DYY20FUNGICIDE USED MORE THAN 1 SPECIES | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/26/2006 | 56YYS99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is UNILAB CHEMICALS & PHARMACEUTICALS PVT.LTD.'s FDA import refusal history?
UNILAB CHEMICALS & PHARMACEUTICALS PVT.LTD. (FEI: 3004919402) has 13 FDA import refusal record(s) in our database, spanning from 10/26/2006 to 10/26/2006.
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. UNILAB CHEMICALS & PHARMACEUTICALS PVT.LTD.'s FEI number is 3004919402.
What types of violations has UNILAB CHEMICALS & PHARMACEUTICALS PVT.LTD. received?
UNILAB CHEMICALS & PHARMACEUTICALS PVT.LTD. 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 UNILAB CHEMICALS & PHARMACEUTICALS PVT.LTD. come from?
All FDA import refusal data for UNILAB CHEMICALS & PHARMACEUTICALS PVT.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.