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Executive Summary

An FDA inspection of Imreg's New Orleans plant alleges that the company did not have a suitable identity test for one lot of the anti-AIDS product Imreg-1. The observations by the FDA investigator, James Green, Jr., are contained in a report issued to the firm at the conclusion of an inspection conducted during the period July 18-Aug. 12. One of Green's observations notes that "there is no identity test for the final product, lot 851022." Regarding production and process controls for Imreg-1, the FDA investigator also observed that "limits have not been set for active and inactive constituents" used for clinical testing of lot 851022. In addition, "the final product does not include a preservative as required for multidose vials," the inspector wrote. FD-483 reports comprise a list of observations that constitute potential violations. It is not uncommon for an FDA investigator to leave an FD-483 report following an inspection. However, FDA concerns about good manufacturing practices can delay decisions for a Treatment IND or other form of extended distribution. The Treatment IND regs call for careful inspections of sponsors' facilities for compliance with GMP requirements, and they stipulate that a clinical hold be imposed on Treatment IND drug sponsors found to be in violation of GMP regs. The nine-page Imreg inspection report describes a multitude of potential violations of FDA GMP requirements. FD-483 citations are correctible. Adverse findings are reported by the investigator to the company and also forwarded to FDA's field office. Firms are permitted to respond to the observations. Firms often respond by indicating why conditions observed are not violative, or by outlining what corrective steps are intended. FDA's district offices evaluate responses and determine whether follow-up regulatory action (beyond a second inspection) is appropriate. Initiated on July 18 ("The Pink Sheet" July 25, "In Brief"), the manufacturing inspection is part of FDA's overall "sponsor review" that will include an examination of clinical investigators and investigations, protocols, and laboratories. An FDA spokesperson noted plant inspections usually occur later in the review process, generally after NDA submission. However, the agency decided to inspect earlier in light of three factors: a request for Treatment IND use is expected; Imreg-1 is an AIDS product; and Imreg announced in March that its drug has been shown to reduce the progression from ARC to AIDS. Other GMP deviations cited in the 483 include the observation that "there is no designated quality control unit" with authority to clear product components, containers, and labeling. Imreg lacks an organizational unit to review "all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product." In addition, the inspector reported: "There are no records of validation of the manufacturing process, filling process, or assurance of aseptic techniques." For example, Green said, there is "no validation that wash procedures for columns are actually cleaning the columns." He also noted a lack of "written control procedures for the issuance of labeling" or for assuring "that correct labels, labeling, and packaging are used for drug products."

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