Simplifying Global Compliance
Items Tagged with '483'
During FDA inspections, manufacturers can use certain techniques to avoid Form 483s, or to respond to FDA observations, Cathy Burgess said during a recent FDAnews audioconference. Read More
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). Read More
The FDA is an agency under increasing pressure to do more with less, according to the FDA’s own enforcement reports, with the number of warning letters dropping even as recalls skyrocket, sources say. Read More
In the Form 483 the FDA issued to Bausch & Lomb's Greenville, S.C. facility, the firm was cited for the following deficiencies: Read More
Andrx failed to properly investigate product discrepancies and out-of-specification results, according to observations listed on the Form 483 the FDA issued to the company after the agency’s reinspection of the drugmaker’s plant in March. Read More
The FDA completed a reinspection of Guidant’s St. Paul, Minn., Cardiac Rhythm Management facility, which resulted in a one-item Form 483, the company announced Feb. 23. Read More
Guidant said last month it is on track to address the FDA’s warning letter concerns about a wide-range of Good Manufacturing Practice (GMP) issues including electronic records and signatures. Read More
The FDA does not plan to make major policy changes to its good manufacturing practice (GMP) requirements following the agency’s recent defeat in a lawsuit against Utah Medical Products (UTMD), a top agency official said. Read More
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. Read More
Guidant says it takes seriously concerns raised in the FDA’s recent Form 483, which cites multiple deficiencies in the company’s quality system (QS) approaches. Read More
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