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Heparin API Manufacturer SPL Draws Warning for Complaint Handling and Supplier Auditing

Inadequate follow up to customer complaints – a key theme in recent FDA drug GMP warning letters – was again on the front burner in a warning letter issued in late January to Scientific Protein Laboratories (SPL) in the wake of the agency’s continuing investigation into the 2008 heparin contamination crisis....

FDA’s Focus On Lab Practices Abroad Continues in Four Recent API Warning Letters

Laboratory practices – a recurrent area of concern in FDA inspections abroad – again took center stage in a series of warning letters issued by the Center for Drug Evaluation and Research (CDER) compliance office to four foreign active pharmaceutical ingredient (API) manufacturers in December....

FDA Re-inspection Findings at McNeil’s Fort Washington Plant Track Those at Las Piedras; Recall Problems Continue

A similar litany of concerns centering on the handling of complaints, deviations and recalls and their interrelationship was raised during FDA’s follow-up investigation at McNeil’s Fort Washington facility completed in mid-December as was found in the follow-up at its Las Piedras, Puerto Rico plant that ended a few weeks earlier....

McNeil’s Compliance Problems Continue With New FDA Inspection Findings and a Recall

Compliance problems continued to plague J&J’s OTC drug subsidiary McNeil in November with the firm announcing the recall of another bolus of children’s medicines made at its Fort Washington plant and the receipt of a substantial 483 from FDA investigators at the conclusion of a lengthy inspection of its Las Piedras, Puerto Rico facility....

Mold Contamination in Claris IV Bags Results in Class I Recalls, Warning Letter and Import Alert

The findings of fungal contamination in IV bags contract-manufactured at Claris Lifesciences’ Ahmedabad, India facility has resulted in a three-product Class I recall, an FDA warning letter and a U.S. import alert on Claris products....

Contamination Control in Aseptic Processing Draws FDA Warning in U.K.

FDA inspection observations in late July of evidence of mold contamination in a Class 100 aseptic suite and inadequate controls in place to prevent it led to a warning letter to Wrexham, U.K.-based CP Pharmaceuticals at the end of October....

Japan’s Foreign Inspections Reveal Communication Chain Gaps

Foreign inspections by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are revealing gaps in the communication chain between marketing authorization holders in Japan, their overseas suppliers and the Japanese caretakers of the supplier’s master files, PMDA’s Liaison Officer with EMA Yoshikazu Hayashi reported at the annual meeting of the Active Pharmaceutical Ingredient Council (APIC) in Barcelona, Spain in late October....

FDA Extends False Claims Act to GMP Violations in $750 Million GSK Settlement

The Department of Justice (DoJ) announced in late October that SB Pharmco Puerto Rico (PR) – a subsidiary of GlaxoSmithKline (GSK) – has agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs produced between 2001 and 2005 at its now-closed Cidra, PR facility....

New Warning Letters in US Focus on Process Validation and Sponsor/Contractor Relations

Drug GMP warning letters issued in mid-October to Hauppage, New York-based Contract Pharmacal and to Advanced Testing Laboratory in Cincinnati, Ohio shed light on FDA’s compliance expectations for two front-burner issues – process validation and sponsor/contractor communications....

Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe....
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