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LEMMON MANAGEMENT WARNED TO TAKE "PROACTIVE" ROLE IN QUALITY CONTROL

Executive Summary

LEMMON MANAGEMENT WARNED TO TAKE "PROACTIVE" ROLE IN QUALITY CONTROL by FDA in a Dec. 2 warning letter "rather than [a] reactive lead in solving quality problems." The letter, dealing with unresolved issues from the agency's July 29-Aug. 18 inspection of Lemmon's Sellersville, Pa. facility, is signed by Philadelphia District Director Loren Johnson. FDA acknowledged receipt of Lemmon's Sept. 1 response to observations made at the inspection but disagreed with or had further questions about details of proposed and completed corrective actions taken by the company. Aside from rebutting details of Lemmon's response, the agency letter asks for improvements in Lemmon's entire quality control process. The letter states: "Since most of your corrective actions deal specifically with problems found during the inspection, we urge you to evaluate your operations as a whole." FDA said that "review and management of daily operations as well as a trouble-shooting quality control unit should reveal and correct [current good manufacturing practices] CGMP problems before an FDA inspection." Management" should consider how any problems found affect the system as a whole and work to repair the system instead of the individual points." Lemmon said it responded to the Dec. 2 warning letter before the 15-working-day deadline and that it is awaiting FDA's response. The company said the observations in the warning letter have been given the "highest corporate priority" and that Lemmon intends to resolve all issues shortly. Lemmon said it interprets FDA's statements to mean that all generic drug manufacturers should have a comprehensive proactive quality control program and that the company agrees with that concept. Ciba-Geigy received a warning letter in July 1991 citing the firm for similar QC lapses. The company established a new regulatory assurance department as a result ("The Pink Sheet" Aug. 19, 1991, T&G-10). No recalls resulted from the inspection findings, Lemmon said, nor do the inspection report or ensuing warning letter prevent the firm from receiving ANDA approvals. Lemmon's last ANDA approval was on Aug. 28 for carbidopa/levodopa, equivalent to DuPont Merck's Sinemet for Parkinson's disease. CGMP deficiencies cited on the original FDA-483 report include the "failure to establish procedures that validate the performance of manufacturing processes such as the adequacy of mixing to assure uniformity and homogeneity" for the firm's sulindac tablets and albuterol sulfate syrup products. Also listed are examples of Lemmon's "failure to document and justify deviations from written procedures." For example, Lemmon performed uniformity of moisture studies for sulindac tabs at a different temperature than that listed in the firm's standard operating procedures (SOPs) without explanation. In its inspection report, FDA found Lemmon had failed to "maintain the purified water system to prevent malfunctions that could alter the safety, identity, strength, quality, or purity of drug products." Examples given by FDA include a leak in the purified water lines located in Lemmon's coating and liquid rooms and the observation that "the sampling of purified water does not simulate actual use in that the inside of the hose at the port is sanitized with bleach prior to sampling." The warning letter indicates that Lemmon's initial response to the inspection findings did not clear up all issues regarding its purified water system. In its letter, FDA asked Lemmon to clarify which testing method will be used in Lemmon's purified water analysis procedure and what steps would be taken if an unacceptable level of Pseudomonas species were found in the water. FDA disagreed with Lemmon's response to the agency's observation that the firm's albuterol sulfate minimum and maximum mixing times were not validated. The agency's Dec. 2 warning letter states: "We disagree...in that you state that validation of the minimum and maximum mixing times were not deemed to be required because the steps were viewed as noncritical." The agency emphasized that "every step of the manufacturing process must be controlled to maximize the probability that the finished product meets all quality and design specifications."
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