McNeil Healthcare, LLC – FDA 483, Feb 13, 2000

This FDA Form 483 was issued to Mr. Thomas W. Laoinski, General Manager of McNeil Consumer Healthcare Inc., a drug manufacturer located at Road 183 Km 19.8 Barrio Montones, Las Piedras, PR 00771. The inspection period was from January 23, 24, 26, 29, 30 to February 5, 8, 13, 2000, and the report was issued on February 13, 2001.

Observations noted during the inspection include: 1. The Installation and Operational Qualification report for the Waters Millennium 32 HPLC Computer System did not verify analytical result calculations (manual vs. automatic) as part of validation. 2. The firm failed to determine measurement uncertainty for analytical and microbalances, specifically the minimum weight, as required by USP 24 chapter <41>. 3. The analytical laboratory did not record the medium temperature in individual vessels during dissolution testing. 4. The firm lacks an effective training program for laboratory personnel, evidenced by analyst error contributing to approximately 59% and 68% of out-of-specification results in the analytical laboratory for 1999 and 2000, respectively.