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Executive Summary

Tablet and capsule manufacturers have a one-in-four chance of avoiding a notice of objectional observations following FDA plant inspections. In 72% of a sample of almost 800 recent inspections, FDA found that the agency's investigator left a company with an observation report (FDA 483) at the end of the investigation. Two types of problems -- in-process production controls and laboratory practices and procedures -- dominate the objections most frequently cited by FDA investigators. In the sample inspections, in-process production controls were cited in 69% of the observational reports and laboratory practices and procedures were cited 63% of the time. The profile of FDA's inspectional interests has recently been developed by the agency's Office of Planning & Evaluation in the form of a report entitled, "An Assessment of Good Manufacturing Practices In Tablet and Capsule Manufacturers." Based on inspection information from the period October 1981 to April 1984, the study attempts to answer two questions for FDA's compliance management staff: (1) "What kind of manufacturing practices do investigators observe as objectionable during drug process inspections of tablet and capsule manufacturers?"; and (2) "Are those observations different when considering characteristics of the establishment and inspection?" EDITORS' NOTE: FDA recognizes the value of its internal study for manufacturers, and the agency intends to make the study available through the National Technical Information Service (NTIS) located in Springfield, Virginia (703) 487-4650. "The Gold Sheet", a monthly publication for quality control executives, covers the report and its findings in the October issue. For a copy of that coverage, contact William Paulson at (301) 657-9830. One characteristic of inspection reports uncovered by FDA was a correlation between alleged in-process production problems and lab practice deficiencies and the severity of regulatory actions recommended by the agency's district offices. Each were found to occur in 84% of those inspections which were rated by the agency's district offices as warranting regulatory action. Another indicator of FDA regulatory action were allegations of stability problems. Only 28% of the firms in the survey were cited for problems with their stability programs; however, those firms accounted for almost half of the companies which were rated for further agency regulatory follow-up. Similarly, if FDA specifically asks for an inspection of a plant due to a complaint or compliance problem, the chances of ending up with a regulatory action are greater than if the agency investigator is performing a standard surveillance inspection. Although only 22% of 203 inspections reviewed by the FDA study were directed in response to a specific problem, those inspections resulted in 48% of the recommended regulatory actions.

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