FDA 483 - McNeil Healthcare, LLC - February 03, 2010

This FDA Form 483 was issued to Nuria Ramiez Ordonez, General Manager of McNeil Healthcare, LLC, a drug manufacturer located at Rd # 183 Km 19.8, Bo. Montones, Las Piedras, PR 00771. The inspection was conducted from January 27, 2010, to February 3, 2010.

The sole observation noted was regarding the Facility and Equipment System. Specifically, equipment and utensils were not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product. The firm failed to ensure products manufactured after cleaning validation activities were free from active ingredients and detergent. The firm lacked procedures for periodic cleaning monitoring of active ingredients and detergent residues to avoid product cross-contamination and to challenge cleaning effectiveness. Examples of cleaning methods validated for non-dedicated manufacturing equipment without an ongoing monitoring program included protocols for "CT Meltaways Area," "Benadryl Ultratab Equipment Train," and "Sudafed PE Nasal Decongestant Tablets."