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Executive Summary

ELKINS-SINN VALIDATION DEFICIENCIES IN TOBRAMYCIN MANUFACTURING are described in a July 10 warning letter to Wyeth- Ayerst. "The tobramycin sulfate injection USP 10 mg/ml and 40 mg/ml products were commercially distributed prior to satisfactory validation of the manufacturing process for each specific dosage form," FDA's Newark District Office said in the warning letter. "Only one lot of each dosage form was tested prior to commercial release." The deficiencies were found during an inspection conducted May through June at the Cherry Hill, N.J. manufacturing facility of the generic injectables subsidiary. On June 16, Elkins-Sinn initiated a Class II recall of the four lots of the antibiotic that were distributed prior to process validation ("The Pink Sheet" Aug. 3, T&G-18). The nationwide recall involves 10 mg/ml, 2 ml multiple dose vials, 40 mg/ml, 2 ml multiple dose vials, 40 mg/ml, 30 ml multiple dose vials and 40 mg/ml, 2 ml syringes. FDA maintains "there was no validation protocol for the manufacture of tobramycin sulfate injection [products]." The warning letter observes that Elkins-Sinn has committed "to cease any distribution of tobramycin sulfate injection until multiple batch process validation is completed for each dosage form." FDA instructed the firm to contact the Newark office after completing the validation so that a reinspection can be scheduled. Other manufacturing and release deficiencies found with the four lots of tobramycin include Elkins Sinn's exceeding the "time restriction from completion of compounding to the completion of filling" for a batch of the 40 mg/ml, 2 ml syringe. That lot also "did not meet Finished Product Release Specifications for Propylparaben...with test results of 76.2%," the warning letter says. The lot of 10 mg/ml, 2 ml vials also did not meet the release specs for propylparaben. During aseptic filling of the 40 mg/ml product, 30 mg vials, "'excessive nitrogen pressure' to the holding jug occurred [and] required adjustment which resulted in low fill volumes," FDA said. Wyeth-Ayerst received another warning letter in May for alleged violations of good manufacturing practices regs at its Guayama, Puerto Rico facility ("The Pink Sheet" June 15, 1992, T&G-12). The violations include lack of appropriate follow-up when analytical data were invalidated, voided or aborted and the lack of a written testing program for assessing the stability characteristics of drug products.

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