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Incomplete cGMP records, active ingredient testing and quality unit shortcomings prompted the FDA to issue a warning letter to Bingbing Pharmaceuticals, an OTC drugmaker in Hubei, China. Read More
Analytical samples for raw materials, in-process and finished products were sent to the Huxley facility for testing, but there was no documentation of the requests. Read More
Data integrity and quality violations netted OTC drugmaker AMO Hangzhou a Form 483 following an FDA inspection of its facility in Hangzhou, Zhejiang. Read More
The agency found that “required tests for quality attributes in the USP were not part of the Chinese Pharmacopeia or [the firm’s] stability protocols.” Read More
Positron emission tomography (PET) firm PETNET Solutions was hit with an FDA warning letter for serious violations including “a state of disrepair and lack of cleanliness” at its Woburn, Massachusetts facility. Read More
Sunrider Manufacturing of Torrance, California drew a Form 483 from the FDA for incomplete complaint investigations and data integrity violations at its OTC manufacturing facility. Read More