Pharmalab 1982 Inc.
FDA import alert and refusal historyLevis, CanadaFEI 3007972013
As of October 25, 2026, Pharmalab 1982 Inc. (Levis, Canada) is on the red list of FDA Import Alert 99-45 (Foods that are or contain an unsafe food additive) for pancake mix; orange flavored, published by FDA on May 13, 2025, is also listed on Import Alert 99-22 (red list) and Import Alert 99-39 (red list) and Import Alert 54-14 (red list), and has 6 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Last import refusal
- Multiple vitamins (mvi-12 vitamin combo) (vitamin) · SUPPL GMP
- Last warning letter
- None found
- Last inspection
- Classified OAI (Official Action Indicated)
Every FDA record for Pharmalab 1982 Inc.
11 records, newest first. Each line links to the FDA page it came from.
2025
- Import alert listingListed on Import Alert 99-45red listPancake Mix; Orange FlavoredSource
2023
- Import refusalSource
Refused, 4 lines in one entry: Multiple vitamins (mvi-12 vitamin combo) (vitamin); Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry 300-1388027-4Show 4 linesHide lines
- Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)SUPPL GMPEntry 300-1388027-4Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry 300-1388027-4Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry 300-1388027-4Source
- Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)SUPPL GMPEntry 300-1388027-4Source
- Import alert listingListed on Import Alert 99-22red listIdeal Protein; Multi-Vita Multi-Vitamin and Mineral SupplementSource
- Import alert listingListed on Import Alert 99-39red listIdeal Protein; Multi Vita Multi Vitamin and Mineral SupplementSource
- Import alert listingListed on Import Alert 54-14red listMulti-Vita K2 Multi-Vitamin and Mineral Supplement; Multi-Vita Multi-Vitamin and Mineral Supplement; Raspberry Hydrolyzed Collagen Liquid Dietary SupplementSource
2022
- InspectionInspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and EconSource
2018
- Import refusalRefused, Cheese, cheddarLIST INGRELACKS FIRMEntry UPS-6654647-5Source
2017
- Import refusalRefused, Imitation maple syrupNEEDS FCENO PROCESSEntry EG6-3942541-2Source
Refusal charges, in plain English
- SUPPL GMP4 refused lines
Dietary supplement CGMP not met
The product appeared to be a dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice (CGMP) regulations.
- LACKS FIRM1 refused line
Manufacturer name and address missing
The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.
- 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).
- NEEDS FCE1 refused line
Processor not registered for canned or acidified foods
The manufacturer appeared not to be registered with FDA as a low-acid canned food or acidified food processor, as 21 CFR 108.25 and 108.35 require.
- NO PROCESS1 refused line
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.
Questions about Pharmalab 1982 Inc.
- Is Pharmalab 1982 Inc. on an FDA import alert?
- Yes. As of October 25, 2026, Pharmalab 1982 Inc. is on the red list of FDA Import Alert 99-45, “Foods that are or contain an unsafe food additive”, for pancake mix; orange flavored; FDA published the listing on May 13, 2025.
- Has FDA refused shipments from Pharmalab 1982 Inc.?
- Yes. FDA refused 6 shipment lines from Pharmalab 1982 Inc. between May 20, 2017 and September 20, 2023. The most recent, on September 20, 2023, was multiple vitamins (mvi-12 vitamin combo) (vitamin), charged as SUPPL GMP (dietary supplement cgmp not met).
- Why did FDA refuse Pharmalab 1982 Inc.'s shipments?
- The most frequent charges are SUPPL GMP (dietary supplement cgmp not met, 4 lines) and LACKS FIRM (manufacturer name and address missing, 1 line).
- When was Pharmalab 1982 Inc. last inspected by FDA?
- FDA's most recent inspection of Pharmalab 1982 Inc. with a final classification is dated June 3, 2022 and was classified OAI (Official Action Indicated).
- What is Pharmalab 1982 Inc.'s FEI number?
- Pharmalab 1982 Inc.'s FDA Establishment Identifier (FEI) is 3007972013.
- Can shipments from Pharmalab 1982 Inc. still enter the U.S.?
- Shipments of pancake mix; orange flavored from Pharmalab 1982 Inc. can be detained without physical examination under Import Alert 99-45; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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