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QUAD CEASES DISTRIBUTION OF 27 PRODUCTS

Executive Summary

QUAD CEASES DISTRIBUTION OF 27 PRODUCTS as a result of internal and external audits of the firm's ANDAs, the manufacturer of generic injectables announced March 16. The distribution halt relates to unapproved manufacturing changes for the firm's products. "Internal and external audits, as well as discussions with the FDA have raised serious questions as to whether Quad made manufacturing changes in certain products subject to approved ANDAs without adhering to FDA regulatory requirements for implementing such changes," Quad explained. A company spokesperson said that the audits were initiated by Quad's management a few months ago to make sure its products complied with their respective ANDAs. The audits have uncovered "potential problems" associated with not fulfilling FDA manufacturing requirements. * FDA said that Quad has informed the agency that "some formula changes had been made without authorization." The agency said that it has been determined that some products appear to have 1-4% more of the active ingredient and/or contain 2-10% more preservatives than what was approved in the ANDAs. FDA is reportedly considering whether it should request a recall of some products. The outside consultant who conducted the external audit is conducting an investigation "to determine the scope of this situation and the company's obligations relative to any product that might have been subject to changes made without proper regulatory approval or notification," Quad said. The company is not disclosing which 27 products are being looked at since the investigation is not yet completed. Quad said that it has halted distribution of the products "until further information can be ascertained as to the extent of any irregularities that might exist." A company spokesperson said that there is no question about the quality of the drugs; however, the firm acknowledges that recalls may follow. "While Quad management believes that distributed products conformed to the release specifications in their approved ANDAs, the company anticipates having to take additional action, including recalls, to assure the public that only properly approved products are shipped in commerce." Regulatory problems at Quad came to light as a result of a pivotal FDA inspection completed in January 1989. The inspectors uncovered various recordkeeping problems after reviewing the manufacturing history of lots for which samples or stability data were submitted to FDA in ANDAs. FDA found that R&D lots were presented in submissions as having been manufactured using full production equipment when they were actually produced in a separate R&D facility under "benchtop" conditions. In FDA's followup inspection of Quad in May-June, the investigators determined that the company had started using its production facility for producing R&D lots. The manufacturer of Quad's R&D lots was discussed by former FDA Division of Generic Drugs Director Marvin Seife, MD, during a May 3 closed session of Rep. Dingell's (D-Mich.) House Energy & Commerce/Oversight Subcommittee. In his testimony, Seife noted that FDA's inspection of the firm was sparked by suspicions about the company's ANDAs. The inspectors, Seife said, found "that in their so-called R&D lab, that these people were making minute amounts of each product in a bowl, nonsterile, setting up some vials or ampules." FDA requires "representative samples from a production run" for validation, "so they were beating the system." Quad's parent firm Par Pharmaceutical found itself in a similar situation earlier this year. The company halted distribution of all of its solid dosage form products in August while it conducted an internal audit of its ANDAs ("The Pink Sheet" Aug. 21, p. 15). Par has been reintroducing or recalling drugs as it reviews each of the products on a case-by-case basis. Par's audit was undertaken in response to an FDA inspection that found manufacturing deficiencies and falsification of data. The inspection resulted in a number of recalls.

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