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FDA REGULATORY FOLLOWUP TO FORM 483 OBSERVATIONS CAN BE AVOIDED

Executive Summary

FDA REGULATORY FOLLOWUP TO FORM 483 OBSERVATIONS CAN BE AVOIDED by a prompt and detailed response by firms to GMP citations, FDA Office of Compliance Director Daniel Michels told a Proprietary Association (P-A) meeting in Philadelphia, Oct. 15. When investigators bring problems to a firm's attention through an FDA-483 report, the firm should take "prompt corrective action" and immediately inform FDA as to that action, Michels stated. "Tell us promptly, completely and specifically what it is that you intend to do or have done to correct the problem. If the problem is not immediately corrected tell us when it will be. If you disagree with us be specific in terms of what you disagree about and why you disagree." Michels cautioned that "absence of feedback can only lead us to the conclusion that your commitment to corrective action is absent or halfhearted at best." Many regulatory actions could have been avoided, Michels added, "had early warning signals," such as 483 observations, been properly heeded. FDAers at the P-A meeting emphasized that any problems or disagreements with FDA-483 observations should also be discussed promptly with the agency through established channels. "If your management sees that there was something that the investigator did not understand properly when he was in the plant, respond promptly to the district so that they can have that information before they submit a regulatory action and it goes forward," FDA compliance official Joel Davis said. Michels advised firms to make the district office the first point of contact in responding to, or discussing problems with the inspectional observations, and not to jump the chain of command in FDA. "Immediately approaching headquarters staff upon discovery of a problem will generally slow matters down and confuse things," Michels stated. In turn, he said, "if you have an honest difference of opinion between your firm and the district office, please attempt to work it out before coming to headquarters." The agency officials at the P-A meeting emphasized that assigning a knowledgeable official from the firm to accompany the FDA investigator during the inspection can forestall unnecessary FD-483 citations. "There are a sizeable number of items that are listed on 483s that would not be listed on 483s if the investigators, when they conduct the inspections, were given all of the information that is available," Mid-Atlantic Region Director Richard Davis maintained. The problem occurs, Davis explained, because "the person who is assigned to go with the investigator on the inspection either does not know the existence of the information, such as certain kinds of records, research data, or whatever it may be, or . . . what the procedure with the plant really is." It is in both the firm's and the agency's best interest to make all the information available during the inspection, Davis noted, and avoid unnecessary 483 entries. Philadelphia District Director Loren Johnson noted that establishing criteria for investigators on what to list on 483s has been a focus of FDA attention during the past year. "The thrust of that has been to eliminate unnecessary comments from the 483s and try and focus on the significant deviations that occur," Johnson explained. FDA expectations for responding to inspectional findings when more than one firm could be affected was also raised as an issue during the P-A meeting. Compliance Office Director Michels advised firms involved in subcontracting arrangements to clarify in the contract how inspectional issues that affect both firms are going to be handled. "You should have built into your business relationship with that vendor full and open knowledge of what transpires between them and the agency to the extent that that impacts on your product or any of your operations," Michels said. Michels maintained that it is less important which of the two parties responds to a 483 report that has been issued than that "the underlying problem is promptly corrected." Mid-Atlantic Regional Director Davis concurred: "We are not concerned all that much about two responds as long as the necessary information gets to us," Davis said. "Just be sure that we get the right information from some source."
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