FDA EIR - Groupe Parima Inc. - April 27, 2018

An FDA surveillance inspection of Groupe Parima Inc., a foreign pharmaceutical contract finished dosage manufacturer located in Saint-Laurent, Quebec, Canada, was conducted from April 23 to April 27, 2018. This inspection, which covered both human and veterinary drug products, including Benzoyl Peroxide Topical Wash, was performed under compliance programs for Drug Manufacturing Inspections, Animal Drug Manufacturing Inspections, and OTC Drug Monograph Implementation, employing a comprehensive systems approach.

The inspection identified three primary issues documented on an FDA Form 483. These observations included the failure to ensure data backup integrity (exactness, completeness, and security), the absence of a written program for routine mechanical equipment checks, and inadequate maintenance of buildings used for drug manufacturing. Furthermore, eight additional concerns were verbally communicated to the firm's management during the inspection's conclusion.

Groupe Parima Inc.'s management committed to addressing these findings and promised to provide a written response outlining their corrective actions within 15 days. The inspection was classified as Voluntary Action Indicated (VAI), indicating that the firm is expected to voluntarily rectify the noted deficiencies.