Captek Softgel International, Inc
⚠️ Moderate Risk
FEI: 3001392778 • Cerritos, CA • UNITED STATES
FEI Number
3001392778
Location
Cerritos, CA
Country
UNITED STATESAddress
16218 Arthur St, , Cerritos, CA, United States
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
MFR INSAN
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.
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2018 | 54YET01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/13/2017 | 54YAH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 473LABELING | Division of West Coast Imports (DWCI) |
| 4/24/2008 | 54AEH99VITAMIN, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 8/27/2007 | 54AEH99VITAMIN, N.E.C. | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/14/2007 | 54AEH99VITAMIN, N.E.C. | 306INSANITARY | Los Angeles District Office (LOS-DO) |
| 3/14/2007 | 54AEH99VITAMIN, N.E.C. | 306INSANITARY | Los Angeles District Office (LOS-DO) |
| 8/8/2005 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 8/8/2005 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 8/8/2005 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 5/9/2005 | 54GET04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS) | 249FILTHY | New York District Office (NYK-DO) |
| 11/17/2004 | 54AEH07NICOTINAMIDE (NIACINAMIDE) (VITAMIN) | Los Angeles District Office (LOS-DO) | |
| 11/17/2004 | 54AEH07NICOTINAMIDE (NIACINAMIDE) (VITAMIN) | Los Angeles District Office (LOS-DO) | |
| 6/18/2003 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 60LBH13CALCIUM CARBASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Captek Softgel International, Inc's FDA import refusal history?
Captek Softgel International, Inc (FEI: 3001392778) has 14 FDA import refusal record(s) in our database, spanning from 3/11/2003 to 6/22/2018.
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. Captek Softgel International, Inc's FEI number is 3001392778.
What types of violations has Captek Softgel International, Inc received?
Captek Softgel International, Inc 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 Captek Softgel International, Inc come from?
All FDA import refusal data for Captek Softgel International, Inc 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.