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Drug Industry Survey Reveals Wide Disparity in Approaches to Controlling Glass Quality

A PDA-sponsored survey of drug and biologic manufacturers reveals a wide disparity among the practices and approaches being taken to ensure the quality of glass vials and syringes and the products they contain....

Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny

A sharp uptick in the number of sterile product recalls due to glass breakage, defects and delamination have the industry, their glass suppliers, and FDA taking a hard look at the reasons for the increase and what can be done to reverse the trend....

FDA Micro Lab Data Concerns Continue with Warning Letter to Second Indian Firm

A warning letter to Ahmedabad, India-based Cadila Healthcare, issued by FDA’s drug compliance office in late June, is the second in as many months to cite an Indian sterile product manufacturer for recording air sampling plate counts that did not match what agency investigators observed during the inspection....

Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India

Evidence of unreliable laboratory data has prompted the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER) to issue warning letters over the past few months to drug manufacturers in China and India....

Baxter Puerto Rico Warning Letter, Recalls Follow FDA Findings of Problems with Complaint Investigations

FDA findings during a mid-2010 inspection at Baxter’s facility in Jayuya, Puerto Rico that appropriate action had not been taken to resolve problems reported in complaints and confirmed in the firm’s own internal investigations resulted in a multi-product recall the following month, a follow-up inspection of a companion facility in Puerto Rico two weeks after the recall, and an FDA warning letter covering both facilities three months later in late January....

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....

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....

FDA Raises Tablet Contractor Validation, Aseptic Processing Concerns at Gilead

Tablet contractor process revalidation and aseptic processing of injectible AmBisome were areas of concern addressed in a warning letter from FDA’s Los Angeles District office to San Dimas, CA-based Gilead Sciences in late September....

Ongoing FDA Concerns with Procedure Compliance, Media Fill Practices and Environmental Excursions at BMS’ Manati, PR Plant Draw Warning Letter

Findings by FDA during a mid-March inspection at Bristol-Myers Squibb’s (BMS) injectable operations in Manati, Puerto Rico of problems with procedure and media fill compliance – previously noted in 2005 and 2009 inspections – contributed to a late-August warning letter to the firm....

FDA Concern with Particle Contamination and Related Investigations Resurfaces in Warning Letter to Sterile Drug Contract Manufacturer

A mid-August warning letter addressing March inspection findings at contract drug manufacturer Hyaluron highlights FDA’s ongoing concerns with particulate contamination problems and their investigation in aseptic manufacturing. The warning letter was issued to the CEO of New York-based Albany Molecular Research, Inc. (AMRI) which purchased ten-year-old Hyaluron in June after the inspection....
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