FDA 483 - BOEHRINGER INGELHEIM PROMECO S.A. de C.V. - May 20, 2022

This FDA Form 483 was issued to BOEHRINGER INGELHEIM PROMECO S.A. de C.V., a drug manufacturer in Ciudad De Mexico, following an inspection. Observations included deficiencies in equipment design for cleaning and maintenance, lack of testing procedures for raw materials used in drug production, and inadequate quality control unit responsibilities regarding procedure approvals and OOS investigations. The findings indicate issues with manufacturing controls and quality system oversight.