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SMITHKLINE BEECHAM DRAWS FDA "WARNING LETTER" FOR VALIDATION

Executive Summary

SMITHKLINE BEECHAM DRAWS FDA "WARNING LETTER" FOR VALIDATION of sterile bulk blending processes at the firm's Piscataway, N.J. bulk antibiotic plant. FDA's Newark District Office issued the warning letter on June 6 based on the findings of a month-long inspection completed April 25. The inspection, the FDA letter states, "revealed that there is no assurance that the bulk synthesis manufacturing processes and the bulk blending processes have been validated in a manner which provides a high degree of assurance that these specific processes will consistently produce a product meeting its predetermined specifications and quality characteristics." SmithKline Beecham is apparently the first drug manufacturer to receive the new warning letter from FDA for GMP violations. FDA announced in late May that it would use the warning letter format to replace regulatory letters and notices of adverse findings as part of the agency-wide effort to streamline enforcement actions ("The Pink Sheet" May 27, p. 5). The SB letter is also significant in reflecting the growing emphasis the agency's field force has been placing on GMP compliance at bulk facilities. Referencing a June 4 response by the company to the April inspection findings, the FDA warning letter notes that the corrective actions cited by the firm "will be checked during a future inspection." The agency's review of SB's response, the letter states, revealed two additional problem areas: "The lack of buffer specifications for finished product in vials and the lack of dose uniformity specifications for products consisting of more than just one drug substance (from FDA-483 of 1/22/90)." The short turnaround time from the conclusion of the inspection of the SB plant in April to the issuing of the warning letter reflects the agency's effort to speed-up its regulatory action procedures. FDA policy regarding the new warning letters, including timeframes for their issuance, was spelled out in a recently added section to the agency's "Regulatory Procedures Manual" (Part 8, Chapter 8-10). The manual states that the letters should be issued by the district, or that a recommendation should be submitted to the center for their issuance, 15 days after completion of the inspection or applicable sample analysis. If consulted, the center should either concur or not concur with the district within an additional 15 days. The regulatory procedures guide advises district directors on the factors that should be considered in reaching a decision to issue a warning letter without headquarters clearance. Direct field issuance should be considered, the manual states, when ** "evidence indicates that a firm, product and/or individual is in violation of the law or regulations to the extent that failure to adequately and promptly achieve correction may be expected to result in enforcement action"; ** "the agency policy is clear concerning the violation(s)"; ** "there is a reasonable expectation that prompt correction will occur"; ** "the nature of and the circumstances surrounding the violation(s) are appropriate to issuance of a Warning Letter"; and ** "the violation does not fall within the specific program areas" for which center concurrence is specified. The manual emphasizes that a warning letter is "not a prerequisite to taking an enforcement action." The agency will bypass the letters and immediately proceed to take enforcement action, the manual explains, when: "The violation reflects a history of repeated or continuous conduct of a similar or substantially similar nature during which time the individual and/or firm have been notified of a similar or substantially similar violation"; "the violation is intentional or flagrant"; or "the violation represents a reasonable possibility of injury or death."
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