FDA EIR - Strebor Specialties, LLC. - February 13, 2019

An FDA inspection of Strebor Specialties, LLC, a liquid filler located in Dupo, IL, was conducted on February 13, 2019. This was the firm's initial inspection and was carried out as part of a work plan following FDA guidance for cosmetic manufacturers. The inspection also served as a follow-up to a previous product recall. The review encompassed the firm's standard operating procedures for production, cleaning, sanitizing, consumer complaints, and recall protocols. Crucially, Strebor Specialties, LLC was not issued a Form FDA 483, Inspectional Observations, signifying that no significant violations or regulatory issues were identified during the inspection. Consequently, there were no findings requiring discussion with management at the close-out meeting. The inspection specifically addressed a recall (RES (b)(4)) of certain (b)(4) products, which were found to contain (b)(4) and carried a potential risk. However, Strebor Specialties, LLC had already ceased manufacturing these particular products in October 2018 and provided a letter denying responsibility for the recall. No signs of pest activity were observed, and samples collected during the inspection were found to be in compliance. This inspection concluded favorably for Strebor Specialties, LLC, with no regulatory actions required by the agency.