Negocios Industriales Real S-.A (Nirsa)
FDA import alert and refusal historyGuayaquil, EcuadorFEI 3009904675
Recorded by FDA as NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA)
As of October 26, 2026, Negocios Industriales Real S-.A (Nirsa) is on the green list of FDA Import Alert 16-05, which exempts its listed products from detention without physical examination under that alert, and has 3 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 16-05 · green list
- Last import refusal
- Sardines (brisling, sprats, pilchards, etc.) · LACKS N/C
- Last warning letter
- None found
- Last inspection
- Classified NAI (No Action Indicated)
Every FDA record for Negocios Industriales Real S-.A (Nirsa)
8 records, newest first. Each line links to the FDA page it came from.
2025
- Import refusalSource
Refused, 2 lines in one entry: Sardines (brisling, sprats, pilchards, etc.)LACKS N/CNO ENGLISHNO PROCESSEntry DP4-3840954-3Show 2 linesHide lines
- Refused, Sardines (brisling, sprats, pilchards, etc.)LACKS N/CNO ENGLISHNO PROCESSEntry DP4-3840954-3Source
- Refused, Sardines (brisling, sprats, pilchards, etc.)LACKS N/CNO ENGLISHNO PROCESSEntry DP4-3840954-3Source
2019
- Import refusalRefused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)LIST INGREEntry 9SX-0000489-5Source
2016
- InspectionInspection classified NAI (No Action Indicated)Foodborne Biological HazardsSource
2013
- InspectionInspection classified VAI (Voluntary Action Indicated)Foodborne Biological HazardsSource
2011
- InspectionInspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological HazardsSource
2009
- Import alert listingListed on Import Alert 16-05green listMahi MahiSource
- InspectionInspection classified VAI (Voluntary Action Indicated)Foodborne Biological HazardsSource
Refusal charges, in plain English
- LACKS N/C2 refused lines
Net quantity statement missing
The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.
- NO ENGLISH2 refused lines
Required label information not in English
Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.
- NO PROCESS2 refused lines
No scheduled process filed
The manufacturer appeared not to have filed a scheduled process with FDA, which 21 CFR Part 108 requires for low-acid canned and acidified foods, so the product is treated as made under insanitary conditions.
- LIST INGRE1 refused line
Ingredients not listed
The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).
Questions about Negocios Industriales Real S-.A (Nirsa)
- Is Negocios Industriales Real S-.A (Nirsa) on an FDA import alert?
- Yes. As of October 26, 2026, Negocios Industriales Real S-.A (Nirsa) is on the green list of FDA Import Alert 16-05, “Mahimahi from Ecuador and Taiwan: histamine, decomposition”, for mahi mahi; FDA published the listing on December 31, 2009.
- Has FDA refused shipments from Negocios Industriales Real S-.A (Nirsa)?
- Yes. FDA refused 3 shipment lines from Negocios Industriales Real S-.A (Nirsa) between November 12, 2019 and January 7, 2025. The most recent, on January 7, 2025, was sardines (brisling, sprats, pilchards, etc.), charged as LACKS N/C (net quantity statement missing).
- Why did FDA refuse Negocios Industriales Real S-.A (Nirsa)'s shipments?
- The most frequent charges are LACKS N/C (net quantity statement missing, 2 lines) and NO ENGLISH (required label information not in english, 2 lines).
- When was Negocios Industriales Real S-.A (Nirsa) last inspected by FDA?
- FDA's most recent inspection of Negocios Industriales Real S-.A (Nirsa) with a final classification is dated November 11, 2016 and was classified NAI (No Action Indicated).
- What is Negocios Industriales Real S-.A (Nirsa)'s FEI number?
- Negocios Industriales Real S-.A (Nirsa)'s FDA Establishment Identifier (FEI) is 3009904675.
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