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A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription. Read More
The FDA cited a Plattsburgh, N.Y., outsourcing facility after an inspection in February and March found serious deficiencies in the company’s cleanliness and sterility practices. Read More
Pharmakon Pharmaceuticals executives routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More
A June FDA inspection left a Washington state pharmacy and compounder with a Form 483 citing unsafe production practices that could lead to drug contamination. Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More
Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets. Read More
Beacon Prescriptions, a compounding pharmacy in Southington, Conn., was warned by the FDA for unsanitary conditions and other federal violations, according to a letter sent earlier this month. Read More