BAXTER's DRUG STERILIZATION PROCEDURES cited by FDA in a July 31 warning letter to the company. The warning letter addresses several deviations from Good Manufacturing Practice Regulations related to the manufacture of "sterile drug products, such as Travasol and Cleocin" at Baxter Healthcare's Carolina, Puerto Rico facility. In addition to the manufacture of sterile Baxter products, the plant reconstitutes some drug products, such as Upjohn's Cleocin, into single-dose units. The warning letter follows an FD-483 inspection report issued June 24. Both documents detail several problems surrounding sterilization procedures at the Puerto Rico facility. For example, the warning letter cites Baxter for: "failure to develop, implement and follow adequate written procedures" for both "the sanitation and maintenance of autoclaves and related equipment" and "the aseptic fill and seal machine" needed to "prevent malfunctions and contamination of drug products." The letter also cites Baxter's failure to "thoroughly investigate the sterilization cycle failure of parts of a batch" and "failure to validate the sterilization process of two autoclaves after a related malfunction and related repairs." Further breaches cited in the FD-483 include a number of inspection findings inconsistent with Baxter's own reports. An FDA inspector noted broken insulation in an autoclave which contradicted Baxter's report of the same day that insulation was adequate; Baxter reported no leaks in its autoclaves on the same day an inspector observed leaks; a plexiglass cabinet in a seal- fill-seal machine was reported sealed to maintain aseptic conditions, but was observed cracked. The FD-483 form also lists a number of GMP violations caused by inadequate inspection procedures; for example, a "waterloop pump alarm" was not included in inspection procedures and failed to sound when the waterloop pump in an autoclave failed. The report also notes: "There was no evaluation of the effect of large amounts of water in the autoclave's . . . insulation. On 5/20/91, the insulation on top of the autoclaves were broken and open to water. Management verbally stated that the overhead water sprinklers inundated the area." Baxter met with FDA Aug. 15 to discuss the problems listed in the warning letter, which Baxter claims were addressed in its response to the findings of the June inspection. Baxter maintains that the facility was never out of compliance with CGMPs and that the plant's products were not affected by the events detailed in the warning letter. Baxter said that FDA sent the company a letter on Aug. 16, following the meeting, requesting more information to clarify a "couple of issues" on which the agency was not satisfied. Baxter planned to respond to the agency's request on Aug. 22 or 23. The Carolina plant continues to manufacture the sterile drugs cited in the letter. FDA has not asked for a recall, Baxter said.
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