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Executive Summary

BIOCRAFT SOP FOR RESAMPLING AND RETESTING BLENDS IS "INADEQUATE," FDA told the generics manufacturer in a Nov. 5 warning letter. The letter, from FDA's Newark District Office Director Matthew Lewis, addresses the findings of a June 1-July 10 inspection of Biocraft's Fairfield, N.J., Paterson N.J. and Fair Lawn, N.J. manufacturing facilities. The letter is a follow-up to the firm's Aug. 21 response to a list of adverse observations (FDA-483) issued at the end of the inspection. Biocraft's standard operating procedure (SOP) for resampling and retesting blend samples for homogeneity is "inadequate, at least [in] its practice as documented" during FDA's inspection, the warning letter states. Inspectors found that for one blend of a product, a failing assay result "was disregarded and three retests were performed using three new weights from the bottle of sample." FDA added that "there was no investigation report describing the decision to disregard the initial result, the reason for the high result, and whether the original sample was retested or an additional sample was taken." While this observation related to an unapproved Biocraft product, the same SOP "applies to all drug products manufactured by your firm," the agency noted. FDA told Biocraft that "unless the analyst [taking the sample] or the firm has a valid reason for discarding a sample result for uniformity testing, that result must be accepted and acted on accordingly." FDA added that it "would have no objection if the investigation included taking more aliquots promptly from the solubilized initial sample to see if an error occurred past the sample weighing stage," but said "it is not acceptable to resample the solid when the purpose of the test is to check for homogeneity." FDA cautioned Biocraft that the lack of an agency-approved resampling SOP could lead to punitive agency action. "Until your firm develops and follows an acceptable procedure for this issue," the warning letter cautions, "the District will recommend that no government contracts be accepted and that no pending ANDAs be approved." Biocraft said in a Nov. 12 10Q filing with the Securities and Exchange Commission that it has responded to the warning letter, that it feels it has adequately addressed all of the issues raised by FDA and "does not expect significant delays in its new drug approvals." FDA's objections in the Nov. 5 letter are similar to those voiced in a March 25 letter to the company. That letter, which addressed Biocraft's response to an FDA-483 from a Dec. 16-Jan. 15 inspection of the Fair Lawn facility, found that Biocraft did not adequately investigate a failed product specification test for its furosemide tablets ("The Pink Sheet" April 13, T&G-8). Specifically, FDA questioned Biocraft's choice of sampling methods for retesting the failed tabs. * FDA's recent letter appears to indicate that the approval of some Biocraft ANDAs has been delayed due to CGMP problems. The letter says of three unnamed drugs: "In addition to the above deviations which apply to marketed drugs, we have recommended to our Center for Drug Evaluation and Research that approval be withheld...because of CGMP deviations." Of five other drugs, the letter states: "An approval recommendation...was withheld because your firm was not ready to manufacture them and because of observations related to the specific products." The letter does state, however, that "your firm's response of August 21, 1992 to the FDA-483 issued at the close of the inspection appears to adequately address the above deviations related to pending ANDAs." Biocraft must "certify in writing" that it has corrected the observations of the June-July inspection "and those listed in this letter." The agency "will not schedule an inspection to verify correction of these conditions until we have received your written certification," the warning letter states. The Nov. 5 letter lists several other observations that were found during the inspection, but which FDA said "appear to have been adequately addressed" by the company's Aug. 21 response. The corrected violations include the lack of a "computer system validation report addressing areas such as data security, change procedures, and record retention for HPLC computerized systems" at Biocraft's Fairfield lab. This system tests Biocraft's cephalexin, cefixime, albuterol, amitriptyline and minocycline products. The agency also had several objections to Biocraft's hydroxylamine method validation data for amoxicillin for oral suspension, including the use of a nonvalidated "non-USP hydroxylamine auto- analysis procedure."

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