MYLAN Pharmaceuticals in the USA is facing further issues after receiving a warning letter from the Food and Drug Administration in relation to inadequate measures to prevent cross-contamination at one of its manufacturing facilities in West Virginia.
The company, which is currently recalling all Alphapharm Dilart products in Australia over a manufacturing issue in India (PD 26 Nov), received a warning letter from the FDA noting failures to sanitise or sterilise equipment as well as improper investigations of discrepancies in medicines that did not meet specifications.
The company said it was addressing the issues, resulting in a temporary disruption in the supply of certain unspecified products.
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