FDA WARNING_LETTER - Alcaparras Luxeapers SLU - January 31, 2012

On January 30-31, 2012, the FDA inspected Alcaparras Luxeapers SLU in Nacimiento, Spain, and found serious deviations from acidified food regulations (21 CFR 108 and 21 CFR 114). The firm's acidified garlic cloves in vinegar and onions in brine were deemed adulterated under Section 402(a)(4) of the Act.

A significant violation was the firm's failure to file information on the scheduled process for acidified garlic cloves and onions in brine, as required by 21 CFR 108.25(c)(2). The FDA also noted other products like garlic in oil, gherkins, and piri piri, which may also be acidified foods, and stated the firm is responsible for determining if these or other products are subject to 21 CFR 108 and 114.

Failure to adhere to these regulations could lead to emergency permit control provisions under Section 404 of the Act or refusal of admission of products into the U.S. under Section 801. The FDA may also assess re-inspection fees for costs incurred due to noncompliance.

The firm must respond in writing within thirty working days, outlining specific corrective actions and providing supporting documentation. Failure to respond adequately may result in further action, including refusal of admission and detention without physical examination (DWPE) of imported products, potentially