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Executive Summary

FDA issued 163 warning letters to drug firms in the first four months of use of the new regulatory action format, according to FDA Office of Enforcement data through the end of the fiscal year (Sept. 30). Since switching in late May from the use of notice of adverse findings and regulatory letters, FDA has issued a total of 614 warning letters: 163 for drug regulation violations, 51 in biologics, 207 involving devices and radiation health, 121 in foods and 72 in veterinary medicine. Discussing the use of the warning letters at an Oct. 3 "Manufacturing and Controls" seminar sponsored by the Nonprescription Drug Manufacturers Association, FDA Office of Compliance Director Daniel Michels noted that the pace at which they are being issued "substantially" exceeds that for regulatory letters in the past. For instance, FDA issued a total of only 498 regulatory letters during all of fiscal 1990 and 370 in fiscal 1989. Michels noted that as of mid-September, 53 warning letters involving good manufacturing practice (GMP) violations had been issued; 20 of these to manufacturers of medical gases. Addressing industry concerns that the FDA field offices may be applying different standards in determining when to issue warning letters, Michels maintained that the districts are following FDA's stated policy in issuing them "only for violations of regulatory significance." Michels noted that there has been "discomfort on the part of the food and drug law bar as well as some quarters in the industry that we are going to be nickling and diming people using warning letters." However, he emphasized, "this is not the case. I have kept my ear to the ground in a number of locations," and "my sense is that the field is not miscuing very often," the compliance office director told the NDMA group. "When they are issuing these warning letters, they are for the right stuff and for serious violations." Michels advised firms that are "uncomfortable" with what's on an FD-483 inspection report or a warning letter to communicate that concern to the investigator on site or to the district office management. "Go back to the district director who signed the warning letter and work it out and make sure you are understanding," Michels suggested. If resolution is not possible there, he said, the next step would be to contact the Office of Compliance's Division of Drug Manufacturing and Product Quality. The problem should be brought to his personal attention or to the Ombudsman's office only if necessary, Michels said. If the firm agrees with the district management on the problems noted in the warning letter, Michels advised, "give the district management or the agency a timetable when you are going to get those things fixed."

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