New Zealand Manufacturer Cited for CGMP Violations

FDA issued a warning letter on Sept. 4, 2015 to Jaychem Industries (Auckland, New Zealand) for violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals observed during an FDA inspection conducted from July 7–10, 2014. The company was also cited for manufacturing misbranded drugs.

In regards to the CGMP violations, the agency stated in the warning letter that the company failed to ensure the quality of API from various suppliers; failed to establish adequate written control procedures; failed to test finished batches for identity and strength of APIs; and failed to provide data to demonstrate that chemical and physical properties of a product remain acceptable throughout the product’s lifecycle.

FDA also cited the company for misbranding because some of the company’s sunscreen products had labels that claimed the products prevented sunburn, which would make them drugs as defined by the Food, Drug, and Cosmetic Act “because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man.”