Liquid Manufacturing, L.L.C. – FDA Warning Letter, Jan 21, 2010

On March 26, 2010, the FDA issued a Warning Letter to Liquid Manufacturing, LLC, following an inspection from January 9-21, 2010, prompted by a consumer complaint about swollen baby food pouches. The inspection found significant deviations from 21 CFR Part 108, 21 CFR Part 114, and 21 CFR Part 110, rendering acidified and acid food products adulterated under Sections 402(a)(3) and 402(a)(4) of the Act.

Key violations included a series of container closure failures, leading to unsealed pouches contaminating the production system and finished products. The firm's fitment/capping equipment was deficient, failing to adequately protect food from contamination. FDA laboratory tests confirmed molds and yeasts in products and microleaks in damaged pouch seams.

Specific regulatory violations cited were: * Failure to file scheduled processes for all acidified food products as required by 21 CFR 108.25(c)(2), although two processes were submitted post-inspection. * Failure to test and examine containers frequently enough to prevent leakage and contamination, as required by 21 CFR 114.80(a)(4), evidenced by numerous swollen and leaking pouches.

The Michigan Department of Agriculture issued a license limitation restricting the firm from processing and distributing acidified "baby food." Liquid