SRI Krishna Pharmaceuticals Ltd - Unit I
⚠️ Moderate Risk
FEI: 3003723117 • Hyderabad, Telangana • INDIA
FEI Number
3003723117
Location
Hyderabad, Telangana
Country
INDIAAddress
C - 4 Industrial Area, Medchal - Malkajgiri; Uppal Khalsa, Hyderabad, Telangana, 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
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.
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 |
|---|---|---|---|
| 2/2/2015 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/20/2014 | 61FCA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/5/2014 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2014 | 61TAB31DOMPERIDONE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/13/2007 | 60LBS99ANALGESIC, N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/7/2006 | 60LAS01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 6/12/2006 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 1/27/2006 | 60LDS01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 1/12/2005 | 64HAS02GUAIFENESIN (EXPECTORANT) | New York District Office (NYK-DO) | |
| 9/27/2004 | 61TCS99ANTI-EMETIC/NAUSEANT N.E.C. | 16DIRECTIONS | Atlanta District Office (ATL-DO) |
| 9/9/2004 | 60LAS01ACETAMINOPHEN (ANALGESIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/15/2003 | 61TCR12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is SRI Krishna Pharmaceuticals Ltd - Unit I's FDA import refusal history?
SRI Krishna Pharmaceuticals Ltd - Unit I (FEI: 3003723117) has 12 FDA import refusal record(s) in our database, spanning from 5/15/2003 to 2/2/2015.
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. SRI Krishna Pharmaceuticals Ltd - Unit I's FEI number is 3003723117.
What types of violations has SRI Krishna Pharmaceuticals Ltd - Unit I received?
SRI Krishna Pharmaceuticals Ltd - Unit I has been cited for 3 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 SRI Krishna Pharmaceuticals Ltd - Unit I come from?
All FDA import refusal data for SRI Krishna Pharmaceuticals Ltd - Unit I 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.