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During its July 8-12 inspection, the agency noted that the firm received several complaints from customers about out-of-specification results they got after performing API tests on products they bought. Read More
A lack of product testing and a deficient quality unit resulted in a warning letter for New York-based Scientific Solutions Global, in addition to unapproved new drug violations. Read More
Dr. Reddy’s inspection woes continue following the FDA’s inspection of its Indian API manufacturing plant in Bollaram, Hyderabad, which revealed multiple violations and netted the pharma giant yet another Form 483. Read More
“Without testing each batch, you do not have scientific evidence that all drug product batches conformed to specifications before release,” the agency said. Read More
A West Jordan, Utah company that manufactures over-the-counter drug products has been hit with a warning letter for multiple issues at its facility, including a lack of API testing and a failure to put quality unit procedures in place. Read More
The firm’s initial response to the mismatched data was insufficient, the agency said, calling the company out for failing to commit to a “comprehensive retrospective evaluation” of data integrity in its manufacturing operations. Read More
The FDA slapped human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturer Stratus BioSystems with a warning letter for violations at its Grapevine, Texas facilities involving its Amniotic Membrane Patch Allograft product. Read More
API slurry was contaminated with “reclaimed water” — water taken from the floor and recycled from drains — that was not tested to prove its suitability for manufacturing APIs. Read More
The clock is ticking on the FDA’s enforcement discretion period for stem cells and other new therapies, and Congress raised concerns and questions with the agency about its plans going forward in a letter last week. Read More