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Labcompliance News, September 2004

September 14, 2004

26-Item FDA 483 and a Warning Letter for API Manufacturer in India

Manufacturing of Active Pharmaceutical Ingredients (API) imported to the United States should follow US FDA regulations such as current good manufacturing practices. To verify compliance with FDA regulations and guidelines the FDA inspects foreign manufacturers. In case of non-compliance the FDA writes inspectional observations on 483 forms and may send the company a warning letter. Failure to promptly correct these deficiencies may result in the refusal to permit APIs into the United States. an API manufacturer in India. A manufacturer in India received a 26 item 483, a warning letter and a detailed establishment inspection report. Deviations have been related to process validation, raw data, system suitability testing, impurity testing, documentation, laboratory instrument calibrations, cleaning validation, laboratory procedures, equipment qualifications, validation of computer data integrity. For summary of the FDA reports and the company's response, click here. The complete set with warning letter, EIR and 483 can be downloaded from the Labcompliance Users Club (44 pages). Non members can preview excerpts.

September 13, 2004

FDA Perspective on Laboratory Inspections


Yvonne McKnight, chemist at the FDA Philadelphia gave a presentation at the IVT conference "Laboratory Controls & Compliance" in Philadelphia on August 16, 2004. More than 150 delegates listened to the presentation entitled: Inspection Issues in the Analytical Laboratory: An FDA Perspective". During the presentation McKnight quoted and discussed FDA regulations and enforcement activities, she gave advice on how to prepare for FDA inspections and reported on recent trends and statistics of inspectional deviations. Highlight of the presentation was a TOP TEN list with 483 inspectional observations. Labcompliance Usersclub members can download the presentation. For preview and ordering, click here. To learn more about FDA inspections click here. 

September 13, 2004

More than 20 New Documents in the Labcompliance Users Club

The Labcompliance users club has been updated with a new user interface and with more than 20 new documents. New additions include SOPs, reference papers and validation examples. New documents from FDA and staff include warning letters, 483's, EIR's, video clips, presentations and guidance documents. A new user interface makes it easy to browse through topics and type of documents. For preview and registration, click here.