Alfred Louie, Inc.

Warning LetterOpen

Mr. Michael Louie, President Mr. Gordon Louie, Secretary Alfred Louie, Inc. 4501 Shepard St. Bakersfield , CA 93313 United StatesFEI 2921033Issued Sep 11, 2024Division of Human and Animal Food Operations West V

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2921033.

Violations6

Issue DateSep 11, 2024

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Alfred Louie, Inc.
Location: Mr. Michael Louie, President Mr. Gordon Louie, Secretary Alfred Louie, Inc. 4501 Shepard St. Bakersfield , CA 93313 United States
FEI Number: 2921033
Country: United States
Issue Date: September 11, 2024
Issuing Office: Division of Human and Animal Food Operations West V
Product Type: Food & Beverages
Status: Open

Summary

Alfred Louie, Inc., a sprouting operation and noodle manufacturing facility in Bakersfield, California, was cited for serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations under 21 CFR Part 117, as well as food labeling violations under 21 CFR Part 101. During an inspection conducted from January through February 2024, the FDA found that the company failed to conduct required hazard analysis to identify and evaluate known or reasonably foreseeable hazards for foods manufactured at the facility, resulting in raw fresh noodle products being deemed misbranded. The company's failure to comply with preventive controls provisions violated section 301(uu) of the Federal Food, Drug, and Cosmetic Act.

Alfred Louie, Inc. FDA Warning Letter, September 11, 2024