Sterility Concern at TEVA's Manufacturing Plant

The FDA issued a warning letter in regards to Teva's sterility and contamination problems at manufacturing plant in Hungary and gave the company a list of quality measures to be met before the plant will be allowed to ship products to the United States.

Problems include incomplete investigation of media-filled contamination on aseptic manufacturing lines, failure to identify microorganisms found in contaminated units, and poor aseptic processing techniques. With all these critiques, Teva announced that they are working on to replace critical and priority products as quickly as possible.

Sources:

http://www.fiercepharma.com/manufacturing/fda-cites-significant-sterility-concern-at-teva-injectables-plant

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