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

Source: https://www.keypedia.com/records/warning_letter/mc-neil-ppc-inc/d7a92e0b-aefa-4d50-8c19-7e9a69408dbd

> FDA WARNING_LETTER for Mc-NEIL-PPC, Inc. on January 19, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mc-NEIL-PPC, Inc.
- Inspection Date: 2012-01-19
- Product Type: Devices
- Office Name: New Jersey District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/diana-amador-toro/66f3f6c5-4cfe-4f40-b4d4-d24ed4618e64)

Company: https://www.keypedia.com/companies/mc-neil-ppc-inc/03a0e11c-7239-46b9-b61c-a44f4dc2f761

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248