FDA EIR - Manchester Tobacco & Candy Co. - October 02, 2020

Manchester Tobacco & Candy Co. underwent an FDA contract inspection on October 2, 2020, at its Manchester, CT facility. The inspection was conducted under the FY 2020-2021 FDA Food Sanitation Contract, reviewing the company's operations for receiving, storing, and distributing shelf-stable candy, snack foods, cookies, and non-alcoholic beverages. The scope included compliance with sections of 21 CFR Part 117, which outlines Current Good Manufacturing Practice (cGMP) regulations for food.

A significant issue identified during the inspection was the firm's failure to provide employee training records. This observation mirrors a previous violation, indicating that the company had not corrected deficiencies noted in an earlier inspection. Despite being informed of past issues, the required training documentation was still unavailable.

While the firm was assessed regarding the Intentional Adulteration Rule, it was determined not to be subject to this rule as its sole operation involves holding shelf-stable food. The inspection concluded with a "Voluntary Action Indicated" (VAI) status, meaning the FDA identified objectionable conditions but expects the company to voluntarily implement corrective actions to address the identified issues, particularly the lack of employee training records, without immediate regulatory enforcement. A form CT-DCP 483, detailing the observations, was issued to the firm's Vice President.