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This article was originally published in The Tan Sheet

Executive Summary

WHITEHALL's SEMICID VAGINAL CONTRACEPTIVE CITED IN FDA WARNING LETTER to the firm listing violations of current good manufacturing practices. Based on a June 21-July 9 inspection of Whitehall's Hammonton, N.J. manufacturing facility, FDA observed "serious violations" of GMPs relating to the "manufacture, testing, holding and distribution of Semicid vaginal contraceptive suppositories," the agency said in the July 29 letter signed by FDA Newark District Director Matthew Lewis. In the five-page letter, FDA pointed to several quality control problems at Whitehall in the manufacture of Semicid. The Semicid active ingredient nonoxynol-9, for example, was found to be out of specification in certain batches, yet was nevertheless distributed by the company. FDA noted that although the nonoxynol-9 used in the product was found to be out of specification on April 2, Whitehall distributed the product on April 22. Distribution of the product continued until June 1, FDA said, despite a rejection of the nonoxynol-9 batch by the company's quality assurance people on May 21. FDA concluded that QC procedures are therefore "deficient in that product is not placed in quarantine and put on hold when 'out of specification' test results are obtained" for batches. Moreover, FDA declared that review and approval of batch records by the QC unit "is grossly inadequate." The agency noted that the QC unit tested the finished product on April 2, the day after the Semicid batch "was reviewed and signed." According to the warning letter, "the batch failed specifications for nonoxynol-9 content but the batch was subsequently released" because an operator "inexplicably released the wrong batch by removing 'not released' stickers from the drums." FDA said the batch was later placed in inventory control by Whitehall's shipping department. Whitehall's procedures for conducting in-house investigations of product failure "and other in-house problems is inadequate," FDA also said, because only a "'fact findings sheet' is generated to notify production personnel of problems encountered during a shift. However, these forms are not addressed in the [standard operating procedures] for investigations." FDA concluded that "there are no instructions" through which the QC unit can be "promptly notified of problems and [there are] no written procedures for the use of the 'fact finding sheets.'" In addition, FDA inspectors discovered that "there is no calculation of the actual number of suppositories produced from bulk formulation after the insert filling operation nor is the theoretical yield percentage calculated." FDA also observed that "a 'zero' tolerance has been established for mold and yeast in Semicid" suppositories "yet manufacturing procedures involving cleaning procedures for equipment and environmental controls do not assure lack of microbial contaminants in the product." For example, certain lots of Semicid were found to contain bacteria including Aspergillus and Penicillium. Part of the problem, FDA speculated, is that the growth media used, blood agar and tripta soy, "are not optimal for the detection of yeast or mold." FDA said that the "optimal media for [detection] of these contaminants are potato dextrose or sabourand dextrose agar." FDA inspectors also observed that growth media used in microbial testing are "not always stored at the manufacturer's recommended storage temperatures," and that the current monitoring system for growth media storage refrigerators "does not assure the detection of any out of range temperature readings during any period of storage." In general, FDA found that microbiological testing of the bulk nonoxynol-9 "is not conducted and the product's bioburden has not been established." Gram positive bacteria found in Semicid, the agency continued, "have not been identified nor has there been any speciation of detected mold contaminants." Bulk bioburden data have "not been established to support the holding of Semicid bulk compound within the mixing kettles during the insert filling operation," the letter adds. Contaminants in finished product also are not completely identified, FDA said, and the "contaminant source and the corrective action to prevent recurrence has not been determined." In one situation, FDA noted that mold was detected in certain Semicid batches, but "microbial examination of the air source of the production area or the rotary heat chamber was not performed." Whitehall said that it has responded to FDA regarding the deficiencies cited in the warning letter and is "working closely" with the agency to bring its procedures and operations in line with GMP and other requirements. The July 29 letter is the second major FDA warning letter received by Whitehall this year. In March, the agency cited the firm for GMP violations concerning the manufacture of its Advil, Anacin, Preparation H and Today sponge products, among others ("The Tan Sheet" April 26, p. 13).

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