The Quality Lowdown: Diversion, Cross-Contamination And PR Mix-Ups
McKesson meets with US FDA over opioid diversion warning letter, while UK MHRA takes risk-based approach to cross-contamination recalls and firm says it’s the other Guardian Pharmacy.
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Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.
Drug compounding pharmacy Guardian Pharmacy Services was ordered to stop manufacturing sterile drugs after ignoring quality problems for too long, bringing to two the number of decrees the Justice Department has filed against drug compounding pharmacies so far this year, which at the current rate may exceed the two consent decrees filed in all of calendar year 2018. The action follows reports that patients administered eye injections of a drug compounded by Guardian during cataract surgery developed vision impairment.
FDA’s drug center has proposed a new program that would allow pharmaceutical manufacturers to attest that drug products submitted for review conform to certain consensus quality standards. The agency said that such a program would improve drug quality, encourage the development of emerging technology and ensure smoother drug reviews.