Choice Laboratories Limited
⚠️ Moderate Risk
FEI: 3006475459 • Ahmadabad, Gujarat • INDIA
FEI Number
3006475459
Location
Ahmadabad, Gujarat
Country
INDIAAddress
Near Bus Stop, Brahmanwada, State Highway, Opposite Jain Temple, Ahmadabad, Gujarat, 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
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
POISON PKG
The article appears to be a drug and its packaging and labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2009 | 65LBJ99PROTECTANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/15/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/15/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/19/2009 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/22/2008 | 63RDY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 11/5/2007 | 56YBJ99ANTIBIOTIC N.E.C. | New York District Office (NYK-DO) | |
| 4/6/2007 | 60QBJ99ANESTHETIC, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/6/2007 | 56GBJ99ANTIFUNGAL N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/6/2007 | 56YBJ99ANTIBIOTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/9/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/2/2004 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 8/2/2004 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 4/16/2004 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/16/2004 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/16/2004 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/16/2004 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/16/2004 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/16/2004 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/16/2004 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Choice Laboratories Limited's FDA import refusal history?
Choice Laboratories Limited (FEI: 3006475459) has 19 FDA import refusal record(s) in our database, spanning from 4/16/2004 to 12/15/2009.
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. Choice Laboratories Limited's FEI number is 3006475459.
What types of violations has Choice Laboratories Limited received?
Choice Laboratories Limited has been cited for 10 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 Choice Laboratories Limited come from?
All FDA import refusal data for Choice Laboratories 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.