Most warning letters set off by 'inadequate' response to 483, ex-FDAer tells AAPS.Dear Reader,As many as 75% of warning letters may have been triggered by the fact that companies drawing 483s after GMP GMP (guanosine monophosphate): see guanine. inspections did not adequately respond to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. investigator's observations, a former FDA compliance official said Jan. 8. Mark Lynch Mark Lynch (born 2 September 1981 in Manchester) is an English footballer currently playing for Yeovil Town. His regular position is at right-back. Previously a promising junior with Manchester United, for whom he made one senior appearance, against Deportivo de La Coruña in , who until February 1999 was the Center for Drugs' pre-approval inspection program manager, told an American Assn. of Pharmaceutical Scientists (AAPS AAPS American Association of Pharmaceutical Scientists AAPS Association of American Physicians and Surgeons AAPS Ann Arbor Public Schools AAPS American Association of Plastic Surgeons AAPS African Association of Political Science ) conference on pre-approval inspections that "inadequate responses" to 483s are leading reasons why companies get warning letters. "This is not only the case for drug manufacturers,"said Lynch, senior compliance consultant for KMI-Parexel, Rockville, MD. In an interview after his talk, Lynch said it also is common for device and biologics manufacturers to get slapped with a warning letter for failing to adequately address the 483. He told the Crystal City, VA, meeting that the major reason for "inadequate" 483 responses is that companies do not address global compliance problems. "Systemic systemic /sys·tem·ic/ (sis-tem´ik) pertaining to or affecting the body as a whole. sys·tem·ic adj. 1. Of or relating to a system. 2. issues need to be addressed," he said. "It's not just putting a bandage bandage /ban·dage/ (ban´daj) 1. a strip or roll of gauze or other material for wrapping or binding a body part. 2. to cover by wrapping with such material. on a leaking tank, but to figure out why all the tanks leave and show FDA how you are going to prevent that [from happening] again." Lynch said his 75% estimate is based on his personal examination of warning letters over the past three years. Lynch advised manufacturers they should have a comprehensive corrective action A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or plan in place at the conclusion of an audit, or to present one to FDA in the 483 response. Lynch said item-by-item responses to 483 observations are okay, but "you need the big picture in there." Still, he said, adequately addressing a 483 will not always avoid warning letters, at least for makers of drugs and biologics. Device manufacturers, however, can avoid a warning letter by adequately responding to a 483 under a pilot program that began in April 1999. Sincerely, The Editors P.S. Lynch's outline on pre-approval audits for makers of active pharmaceutical ingredients is $4 plus retrieval, Doc. 9763W. |
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