483
Computer Programs & Systems IncFDA 483 - Computer Programs & Systems Inc - September 13, 2023
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An FDA inspection of Computer Programs & Systems Inc. in Mobile, AL, a medical device manufacturer, identified three significant quality system deficiencies. The firm failed to establish adequate procedures for design control and statistical techniques for its Blood Establishment Computer Software. Additionally, the company did not properly document corrective and preventive actions related to programming changes and software updates.
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