FDA 483 - Procter & Gamble Manufactura S. de R.L. de C.V. - June 27, 2025

An FDA inspection of Procter & Gamble Manufactura S. de R.L. de C.V. in Naucapan, Mexico, an OTC human drug manufacturer, revealed significant deficiencies. The firm failed to thoroughly investigate an empty bottle customer complaint due to inadequate check weigher validation. Additionally, batch production records were deficient, lacking proper data integrity controls and identification of personnel supervising critical steps in electronic spreadsheets used for weight verification.