View Cart  

Cispharma Gets Form 483 Over Testing, Drug Quality Concerns

Cispharma has received a Form 483 with several manufacturing observations, including a lack of evidence that a distributed portion of a lot was acceptable. The reserve samples had “scarred and eroded caplets,” the April 23 form notes. FDA investigators also found the company’s manufacturing and packaging processes for drug products had not been validated.    
Drug GMP Report