Divi's Laboratories Ltd. (Unit II)
⚠️ Moderate Risk
FEI: 3004149463 • Visakhapatnam District, Andhra Pradesh • INDIA
FEI Number
3004149463
Location
Visakhapatnam District, Andhra Pradesh
Country
INDIAAddress
Chippada Village, Annavaram, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh, India
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
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 |
|---|---|---|---|
| 12/29/2020 | 61WCS18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/26/2017 | 60LIR85MESALAMINE (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 4/10/2017 | 60CAS09PHENYLEPHRINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 9/1/2006 | 60CCS09PHENYLEPHRINE HCL (ADRENERGIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Divi's Laboratories Ltd. (Unit II)'s FDA import refusal history?
Divi's Laboratories Ltd. (Unit II) (FEI: 3004149463) has 4 FDA import refusal record(s) in our database, spanning from 9/1/2006 to 12/29/2020.
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. Divi's Laboratories Ltd. (Unit II)'s FEI number is 3004149463.
What types of violations has Divi's Laboratories Ltd. (Unit II) received?
Divi's Laboratories Ltd. (Unit II) has been cited for 5 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 Divi's Laboratories Ltd. (Unit II) come from?
All FDA import refusal data for Divi's Laboratories Ltd. (Unit II) 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.