A Canadian company that sells topical skin treatments is in trouble with the FDA, which says what it needs is a dose of good manufacturing practices.
The FDA last week issued a warning letter to Toronto-based Cellex-C International. The warning letter suggests the company hire a consultant, given that the plant failed to meet even basic FDA expectations for producing approved products. It comes after the FDA put the company's pharma products on its import alert list in June.
In email, the company say: "The warning letter was ONLY in relation to SPF sun care products (which are classified by the FDA as ‘pharmaceuticals’) and were already being phased out at the time of the inspection. We have not manufactured or sold those products for several months."
Among problems noted in a January inspection was the fact that the company did not test active ingredients coming in the door—instead, it relied on the supplier’s certificate of analysis—or its finished products going out the door to determine if they met specifications, including for identity, strength and quality.
It didn’t have written standards for its quality control people, like how they should handle customer complaints. It also didn’t have written procedures for its manufacturing processes. Further, Cellex-C wasn’t producing any batch production records with basic information about “critical steps” in the filling and packaging operations, the warning letter reads.
While most manufacturers have to know at least the basics, FDA inspections still turn up some producers with little understanding of the rigorous requirements the FDA enforces. Earlier this year, it cited the Maharashtra plant of Indian drugmaker Badrivishal Chemicals & Pharmaceuticals for using river water without scientific evidence that the system is capable of producing water that meets quality standards, among other issues.
Editor's Note: The story was updated to