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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The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable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
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
The FDA sent a warning letter to Ranier’s Compounding Laboratory, based in Jeannette, Pa., noting serious deficiencies in sterile procedures and GMPs. Read More