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Significance of 483 Observations Depends on Product Impact, FDA Compliance Officials Explain

FDA compliance officials are stressing that their judgment of the significance of an investigator's 483 observation is case-specific, reflecting its implications for the quality of product(s) and the firm’s transparency with the agency about that potential impact....

Baxter Resolves FDA Warning Letter For Puerto Rico Sites, CEO Reports

Baxter has closed out an FDA warning letter issued in January for problems the agency found at two of its Puerto Rico plants, the firm’s CEO Robert Parkinson said in a third-quarter earnings call in late October. FDA findings during a mid-2010 inspection at Baxter’s facility in Jayuya, Puerto Rico that appropriate action had not […]

FDA Warning Letter to Chinese API Firm Cites Cross-Contamination Concerns

This news brief is provided as a service to IPQ subscribers.

FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation

FDA’s growing experience with the field offices it has established in India, China and eight other countries is substantiating their benefit in boosting the agency’s efficiency and effectiveness in regulating a global supply chain....

J&J Board Report Explores Causes of McNeil’s Compliance Breakdowns

A report on an inquiry by a committee of J&J board members into the firm’s recent compliance problems provides insights into how staff reduction, acquisition integration, and communication gaps between operations, company management and the board can contribute to compliance breakdowns in a big pharma organization....

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....

OOS Result Handling Continues as Dominant Theme in FDA Warning Letters Issued Abroad

Giving adequate attention to out-of-specification (OOS) results in batch release decision making and investigation follow up continues as the dominant theme in 2011 in GMP warning letters issued to foreign companies by FDA’s drug and biologic compliance offices....

Warning Letter to API Contract Testing Lab Cites Data Misrepresentation to Customers

A recent FDA warning letter to US-based API contract testing lab Toxin Technologies highlights the agency’s ongoing concern with the communication between contractors and their customers....

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....
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