Almi Inc., a Philadelphia, PA-based pasta and pastry manufacturing plant is misbranding its products, but that’s not its worst offense.
Worse is not registering its very existence with the U.S. Food & Drug Administration (FDA).
“Our records indicate that, to date, your facility has not registered with FDA, despite the fact that you were provided with information on how to register during our March 2009 inspection,” FDA Philadelphia District Director Kirk D. Sooter said in a formal “Warning Letter” to Almi Inc. President Alexander Lev.
The “Warning Letter,” released Nov. 24th, found the raw material source manufacturer was in serious violation of the Federal Food, Drug, and Cosmetic Act for misbranding filled pasta and pastry-products, such as pierogies and blintzesa.
In the letter the FDA said:
- Pierogi with Farmer Cheese, Pierogi with Potatoes and Home Style Dough are misbranded because they fail to declare all major food allergens.
- Pierogi with Farmer Cheese, Pierogi with Potatoes and Home Style Dough are also misbranded because they are fabricated from two or more ingredients, but the label fails to list the common or usual name of each ingredient as required.
- Pierogi with Farmer Cheese, Pierogi with Potatoes and Home Style Dough are further misbranded because nutritional information is not provided in the appropriate format.
- Product labels fail to list the amount of trans fat as required.
- Pierogi with Farmer Cheese, Pierogi with Potatoes and Home Style Dough are also misbranded for not disclosing the net quantity on the label.
FDA also warns that the “owner, operator, or agent in charge” of the facility must register it immediately.
“As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law,” the FDA’s Sooter wrote.
Almi Inc. is advised it may register with the FDA by fax, mail, or electronic means. It has 15 working days to advise FDA on steps it is taking to come into compliance with the law.
A Texas peanut processing plant owned by the now bankrupt Peanut Corp. of America operated for more than two years without state or federal registration. It was only discovered after its parent company caused a national Salmonella outbreak that killed nine and sickened more than 700.