Adcock Ingram Healthcare
⚠️ Moderate Risk
FEI: 3005145029 • Aeroton, Gauteng • SOUTH AFRICA
FEI Number
3005145029
Location
Aeroton, Gauteng
Country
SOUTH AFRICAAddress
1 Sabax Road, , Aeroton, Gauteng, South Africa
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
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2011 | 24AEE08LIMA BEAN | Los Angeles District Office (LOS-DO) | |
| 2/7/2011 | 37JCT08TOMATO SAUCE (WITH OTHER INGREDIENTS) | Los Angeles District Office (LOS-DO) | |
| 2/7/2011 | 37JVE08TOMATO SAUCE (WITH OTHER INGREDIENTS) | Los Angeles District Office (LOS-DO) | |
| 8/25/2006 | 25JCI08RED BEET (ROOT & TUBER VEGETABLE) | Los Angeles District Office (LOS-DO) | |
| 8/25/2006 | 22CCT99VINE FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 8/25/2006 | 33KGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Adcock Ingram Healthcare's FDA import refusal history?
Adcock Ingram Healthcare (FEI: 3005145029) has 6 FDA import refusal record(s) in our database, spanning from 8/25/2006 to 4/22/2011.
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. Adcock Ingram Healthcare's FEI number is 3005145029.
What types of violations has Adcock Ingram Healthcare received?
Adcock Ingram Healthcare has been cited for 6 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 Adcock Ingram Healthcare come from?
All FDA import refusal data for Adcock Ingram Healthcare 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.