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FDA Would Like 483 Responses to Also Address Investigator Concerns Expressed Verbally

Apr 21st, 2012

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FDA field compliance officials are recommending that concerns raised verbally during a GMP inspection be addressed in writing by the firm either in its response to a 483 or independently, whether or not a 483 is issued.

Although the discussions are documented in the establishment inspection report (EIR), a written response to the agency indicates that the firm listened and took the investigator’s comments seriously.

The advice on recognizing the investigator’s verbal comments was one of many valuable insights on what FDA is looking for from companies in responding to 483s provided by Atlanta District Office Compliance Branch Director Phillip Campbell at the University of Georgia/FDA annual GMP conference in March.

Campbell commented that a written response to discussion items that do not appear on the 483 help build the company’s credibility and is a “win-win” situation. He added that the 15-day 483 response expectation does not apply.

The compliance official’s presentation at the UGA meeting encompassed:  ● the history of the form 483 observation report ● how 483 observations are determined ● the decision whether to respond ● how the agency views responses ● planning a response ● keys to the response, and ● what to expect from the agency after the response is submitted. (Campbell’s complete remarks are included at the end of the story).

During the Q&A after Campbell’s talk at the Georgia conference, the field veteran also provided insights into how to deal with inspectors that are not following agency SOPs, why an affidavit is presented at the end of the inspection and its significance, the reasons for agency delay in sending EIRs to inspected firms, and his district’s experience with inspections of virtual companies.

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