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FDA Enforcement And Compliance In Brief

Executive Summary

FDA traces B. cepacia to PharmaTech, Nippon Workers blocked FDA investigator, Yangzhou Hengyuan used wrong API, FDA bans two Chinese firms, and Kaley to provide FDA data integrity training.

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The Quality Lowdown: Recalls And Shortages

EpiPens get new lease on life, though not like nationally stockpiled AtroPens got, while B. Cepacia humbles King Bio and valsartan impurity rouses science to action. More drug recalls, more warning letters, more import alerts are announced, while a new counterfeit detector makes its debut.

Lawsuit, Warning Letter Mark Return Of B. Cepacia As GMP Issue

Lawsuit over infant's death and warning letter over recurring contamination underscore the importance of screening for Burkholderia cepacia and when found, removing the microorganism from pharmaceutical manufacturing processes.

PharmaTech’s Water Problem Reaches OTCs In Ninjacof Recall

Ninjacof cough and cold products are recalled by Richland, MS-based marketer Centurion Labs as a precaution after FDA warns the firm of risk for contamination by burkholderia cepacia, a pathogen that can cause infections in patients with compromised immune systems.

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