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Theqmnweeklybulletin

Oct. 19, 2012

Vol. 4 No. 42

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Warning Letter Lays Out CAPA, Complaint Violations at Kit Company

First Medical Source, a Laguna Beach, Calif., company that assembles pain management kits and distributes infusion supplies, has been warned for design control failures and other quality system violations. Read More

OIG to Continue Investigating FDA’s REMS Program in 2013

During the coming year, the HHS Office of Inspector General (OIG) will continue examining the risk evaluation and mitigation strategies (REMS) program and expects to release findings next year, the office says in its fiscal 2013 work plan. Read More

Drug Withdrawals in EU Must Be Justified Under New Pharmacovigilance Rules

Manufacturers withdrawing their drugs from any market in the EU will now have to notify competent authorities of the reason, according to amended pharmacovigilance rules adopted by the Council of the European Union Oct. 4. Read More

Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance

Devicemakers praised FDA efforts to craft guidance on the agency’s refuse-to-accept policy for 510(k) premarket notification submissions, but took issue with many specifics, including what would happen if a backlog causes the FDA to miss its proposed 15-day timeline. Read More

FDA Raids Compounding Center Facilities, Investigates More Drugs

FDA investigators and local police Tuesday raided the Framingham, Mass., facilities of the compounding pharmacy whose steroid injections are linked to a recent fungal meningitis outbreak. Read More

Cooper Division Gets Closeout on Complaint Handling Warning Letter

CooperSurgical subsidiary Norland got FDA closeout on a warning letter the company received for deviations in complaint handling and good manufacturing practices at its Fort Atkinson, Wis., plant. Read More

Antacid Maker Gets Form 483 for Poor Probes Into Bad, Smelly Batches

Brioschi Pharmaceuticals, a maker of antacid products, was handed a Form 483 for lax investigations into out-of-specification lots released to market and complaints of odiferous drugs. Read More

India Draft Guidance Aims at Better Control of Biologics During Transport, Storage

Distributors of biological products must maintain records of temperature monitoring data and check temperatures during transport and storage at defined intervals, according to a draft guidance by India’s Central Drugs Standard Control Organization (CDSCO). Read More