Items Tagged with '483'


FDA Releases 2007 Investigations Operations Manual

The FDA added noncompliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM).

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Guidant's Response to Form 483 Emphasizes Part 11 Controls

Although Guidant disagreed with the FDA’s recent observation of apparent software validation and electronic records control violations, the company said it would examine and strengthen the relevant in-house requirements and implementation guidelines to ensure compliance with 21 CFR Part 11.

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