FDA EIR - Assemblers Inc. - October 19, 2022

An FDA inspection of Assemblers Inc., a snack food manufacturer located in Chicago, Illinois, was conducted on October 19-20, 2022. The inspection, preannounced by Investigator Patel, was a comprehensive review that also included a limited scope assessment of Preventive Controls for Human Food (PCHF), guided by the Code of Federal Regulations Title 21, Part 117. The primary focus areas included general warehousing operations, sanitation, and pest control, alongside a detailed review of fourteen consumer complaints. A significant outcome was that no FDA Form 483, 'Inspectional Observations,' was issued at the conclusion of the inspection, indicating that no significant regulatory violations or deficiencies were formally identified. Furthermore, the report noted no refusals were encountered, no samples were collected, and no pest infestations were observed. The consumer complaints reviewed covered various concerns, such as foreign objects (e.g., a blue utility cloth, burnt oil residue, a two-inch plastic rope) found in popcorn, and product consistency issues like sugar clumps. More critically, several complaints detailed severe adverse health reactions, including vomiting, gastrointestinal burning, loss of consciousness, and breathing difficulties, reported after consuming the 'One Chip Challenge' product. Assemblers Inc. management provided explanations, attributing some issues to isolated employee adherence lapses or inherent product characteristics, and redirecting responsibility for 'One Chip Challenge' complaints to the brand owner, stating the product met specifications. Given the absence of a Form 483, no specific regulatory actions were mandated for Assemblers Inc. by the FDA.