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.
The manufacturer also failed to properly calibrate its equipment. For example, the firm did not calibrate a temperature gauge located in its cosmetic manufacturing area, a room where the firm stored raw materials used in manufacturing its OTC drug products, and it used non-calibrated weight sets to calibrate balances on site using during testing and manufacturing.
In addition, the firm’s cleaning procedures were deficient. It did not confirm that equipment used in manufacturing was properly cleaned and failed to establish clean hold times for manufacturing equipment, including but not limited to filling equipment and utensils.
The agency also noted that the firm failed to perform process validation for one of its commercial drug products, an OTC spray, and stored raw materials used in manufacturing in conditions with uncontrolled humidity and temperature.