FDA 483 - Kenvue Brands LLC - April 30, 2010

The FDA Form 483 document details numerous violations at the Fort Washington facility, primarily concerning quality control, production, and laboratory procedures.

**Facility and Operation Details:** The inspection covers the Fort Washington facility, manufacturing Children's and Infant's Tylenol drug products, including Dye-Free Tylenol Suspension Drops.

**Violations and Observations:** * **Quality Control Unit Deficiencies (Observation 1):** The Quality Control Unit (QA) failed to reject raw materials with known gram-negative organism contamination, approving them for use in Tylenol products. QA and Compliance departments lacked adequate laboratory facilities, neglected validation protocol review, and were deficient in complaint follow-up, tracking, and trending. * **Lack of Written Procedures for Production and Process Controls (Observation 2):** No written procedures existed to ensure drug product identity, strength, quality, and purity. Specifically, process validation for Infant's Dye-Free Tylenol Drops was absent, and compounding/transfer processes were not in a "state of control" after batch size changes. * **Inadequate Mixing Control (Observation 3):** Control procedures did not ensure adequate mixing for uniformity and homogeneity. * **Failure to Monitor Manufacturing Processes (Observation 4):** Control procedures did not validate manufacturing processes causing variability, such as agitation speeds and times, leading to super potent batches. * **Non-Adherence to Production and Process Control Procedures (Observation