NIG Nutritionals Limited - Paerata
⚠️ Moderate Risk
FEI: 3017228617 • Pukekohe, Auckland • NEW ZEALAND
FEI Number
3017228617
Location
Pukekohe, Auckland
Country
NEW ZEALANDAddress
Paerata, 25 Crown Road; Rd 1, Pukekohe, Auckland, New Zealand
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
LACK NOTIF
Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification conditions required by 412(c) or 412(d), Prohibited Act, Section 301(s).
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
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.
NUTR UNIT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10.
NEEDS ACID
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 due to inadequate acidification.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2023 | 40PGT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | Division of Southeast Imports (DSEI) | |
| 7/16/2023 | 40PYT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | Division of Southeast Imports (DSEI) | |
| 7/16/2023 | 40PYY01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | Division of Southeast Imports (DSEI) | |
| 7/14/2023 | 40PYT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | Division of Southeast Imports (DSEI) | |
| 7/14/2023 | 40PYY01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | Division of Southeast Imports (DSEI) | |
| 7/5/2023 | 40PYT99OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA | 2160LACK NOTIF | Division of West Coast Imports (DWCI) |
| 6/21/2023 | 40PFT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | Division of Southeast Imports (DSEI) | |
| 6/21/2023 | 40PFT99OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA | Division of Southeast Imports (DSEI) | |
| 6/21/2023 | 40PFT99OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA | Division of Southeast Imports (DSEI) | |
| 6/14/2023 | 40PYT01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA | 2160LACK NOTIF | Division of Southeast Imports (DSEI) |
| 12/13/2021 | 41GHE02NUTRTIONALLY INCOMPLETE FORMULATIONS (PROTEIN, CARBOHYDRATE OR FAT MODULARS) | 48NEEDS ACID | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NIG Nutritionals Limited - Paerata's FDA import refusal history?
NIG Nutritionals Limited - Paerata (FEI: 3017228617) has 11 FDA import refusal record(s) in our database, spanning from 12/13/2021 to 7/16/2023.
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. NIG Nutritionals Limited - Paerata's FEI number is 3017228617.
What types of violations has NIG Nutritionals Limited - Paerata received?
NIG Nutritionals Limited - Paerata 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 NIG Nutritionals Limited - Paerata come from?
All FDA import refusal data for NIG Nutritionals Limited - Paerata 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.