Montreal Manufacturer Called Out for Cleaning, Testing Issues
The FDA hit Eau Zone Huiles Et Fragrances with a Form 483 after an inspection determined the OTC manufacturer had numerous deficiencies at its Montreal, Quebec facility, including cleaning, testing and drug storage issues.
The inspector, who visited the facility in December, found that the firm had a deficient supplier qualification program, as it did not evaluate the supplier’s good manufacturing practices. The firm also had no quality agreement with U.S. customers assigning roles and tasks such as recalls, field alerts and complaints.
The inspector noted that the firm did not test an adequate number of batches to determine an appropriate expiration date and it did not conduct an ongoing annual long term stability study for OTC commercial drugs that were shipped to the U.S. market.