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Executive Summary

Zenith Labs has implemented a stability testing program which provides for "the appropriate stability testing intervals of all drug products and for the review of the generated data," according to a June 3 agreement with FDA's Newark District Office. The company has also agreed to complete a full validation of its drug manufacturing facilities, equipment and processes by the end of 1986. The agreement states that the validation will cover procedure "including but not limited to: 1. blending/granulation, 2. compression/encapsulation, 3. coating, 4. raw materials, 5. analytical methodology." Zenith submitted a validation protocol and the status of the validation of all its drug products along with the agreement letter. The June 3 agreement with FDA follows a series of agency inspection reports questioning the firm's stability testing and documentation procedures. The agreement with FDA indicates that Zenith and the agency have identified the required corrections to alleviate agency concerns and have worked out a schedule for revisions by the company. The extent of FDA's concerns about production processes prior to the June 3 agreement are indicated by Zenith's recall of 63 lots in May. The June 3 agreement also calls for Zenith to cease manufacturing and marketing drug products, including various strengths of chlorpromazine and hydroxyzine tabs. During inspections of Zenith's facilities earlier this year, FDA alleged that the method of manufacture or the composition of the products had been changed without prior FDA approval. Zenith Will Stop Marketing Nitroglycerin Caps Until ANDA Approval Is Granted By Agency The company company further agreed with FDA to cease marketing nitroglycerin caps. FDA says that Zenith does not have an approved NDA or ANDA for the caps. Zenith believed that it had been marketing the nitroglycerin under an ANDA owned by the ingredient manufacturer. Zenith believed that it was referenced under that ANDA as the encapsulator. Zenith has agreed with FDA to discontinue marketing the nitroglycerin while awaiting an ANDA in its own name to be approved. The company says an ANDA application has been filed. The June 3 agreement begins to bring to a close regulatory discussions between Zenith and FDA arising from inspections in late 1985 and early 1986. Among observations included on an FD 483 report issued the firm by agency investigators Robert Miranda and Peggy Mayo in March, 1986 were that the firm lacked adequate stability data to support the expiration date on certain products in that: the firm's data revealed that certain lots had failed to meet the NDA dissolution requirements during testing; there was inadequate investigation of these failures; some scheduled test periods had been missed; and there was a lack of stability data for certain lots that had been reworked. The report also cited the firm for not making FDA "aware of numerous stability failures covering NDA drug products to assure their proper review." For example, the report stated, in regard to one of Zenith's products the stability failures observed "were submitted as part of routine annual reports without any attention made that dissolution failures had occured. This stability data was usually presented as a typed summary which listed only the average dissolution results." This was misleading, the investigators alleged, "in that most dissolution failures occurred only after reviewing the individual tablet results."(ITEM 150)[EDITORS' NOTE: Due to the normal time-lag between recalls and publication of the recalls by FDA, the May recalls are listed on the FDA Enforcement Report for July 16, 1986 printed on page T&G-8 of this issue. "The Pink Sheet" carried a news item on the Zenith recalls in a previous issue, June 2, T&G-9].

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