APP Pharmaceuticals has received a warning letter from the Food and Drug Administration.
The letter notified the Staley Road manufacturer that the FDA expects it to “undertake a comprehensive and global assessment” of its operations, particularly its “aseptic processing capabilities.”
The FDA inspected the plant in July, citing several “significant violations,” including insects found in vials of finished product, products with missing labels, a failure to follow quality- control procedures and improper investigating of customer complaints.
The latest letter says APP failed to properly address or correct the violations in its July response to the inspection. A statement from APP’s board of management said that the company has “full confidence” in its products’ quality and that it expects to respond satisfactorily to the FDA’s concerns.
The warning letter also said APP is manufacturing certain prescription drugs without an approved application. APP said the five drugs in question were “grandfathered,” or on the market long enough not to require FDA approval prior to 2006.
Source:
http://www.buffalonews.com/business/article744342.ece
