FDA EIR - Kleen Test Products Corporation - May 20, 2016

An FDA inspection of Kleen Test Products Corporation in Port Washington, WI, was conducted from May 18 to May 20, 2015, under Compliance Program 7356.002 for Drug Manufacturing. The inspection focused on the firm's Quality and Labeling Control systems for products such as OTC oral rinses, wipes, and lotions. While a prior observation regarding inadequate cleaning was resolved, the inspection revealed two primary concerns discussed verbally with management.

First, Kleen Test Products was conducting annual product reviews for a customer without complete access to consumer complaints, including adverse events. This practice compromised the thoroughness of their product quality assessments. The regulatory framework requires comprehensive data for such reviews, necessitating a revision of their quality/technical agreement with the customer to ensure full complaint disclosure and shared responsibilities.

Second, the company inadequately investigated Out-of-Specification (OOS) results for an OTC acne wipe. Stability testing indicated the product failed to meet its 2-year expiration date due to issues like weight loss and salicylic acid concentration changes. Despite this, manufacturing and distribution continued, which constitutes a violation of Good Manufacturing Practices (GMPs) for ensuring product quality and supported expiration dating.

Management acknowledged these issues and committed to corrective actions. These include revising quality agreements to facilitate complete complaint data sharing for annual product reviews and ensuring robust OOS investigations are completed, halting production of products with unconfirmed stability.