FDA WARNING_LETTER - Mc-NEIL-PPC, Inc. - January 19, 2012

On December 12, 2011, through January 19, 2012, an FDA inspection of McNeil-PPC, Inc. in Skillman, New Jersey, identified significant violations of the Quality System regulation (21 CFR Part 820) for various devices including K-Y products, Visine for Contacts, O.B. Tampons, Reach Floss, and Stayfree/Carefree menstrual napkins. The inspection found these devices adulterated under section 501(h) of the Act due to non-conformity with good manufacturing practices.

Key violations include: 1. **Failure to establish and maintain adequate complaint files and procedures (21 CFR 820.198(a))**: Numerous K-Y Liquibeads complaints, including medical complaints and those with specific subject codes, were not adequately evaluated, investigated, or justified, and some were closed based on invalid lot number assumptions. 2. **Failure to promptly review and investigate MDR reportable complaints (21 CFR 820.198(d))**: Complaint investigation procedures were not effectively implemented, leading to incomplete investigations and failure to meet review timeframes for 9 out of 19 MDR reportable complaints. This was a repeat deficiency from a 2009 inspection. 3. **Failure to establish and maintain adequate procedures for validating device design (21 CFR 8