The FDA hit a drug manufacturer in Dresden, Germany with a warning letter for serious violations, including a lack of API and stability testing.
The agency called out Dental-Kosmetik for inadequately testing an incoming API for identity, and for failing to validate the reliability of its suppliers’ analyses.
The firm’s process validation consisted of testing the first production batch “followed by a joint decision between your research and development and quality assurance departments on whether or not to release the batch,” the agency noted. The FDA requires that the decision be made by the quality control unit.
The firm also strayed from its batch manufacturing instructions, allowing a bulk batch that was out-of-specification to get passing results for viscosity and density.