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Weekly UpdatesWyeth Nutritionals, Georgia, VT, Vermont District Wyeth Nutritionals, (WNI) St. Davids, PA,
contacted FDA on Jan. 23, 2002, to report that during microscopic examinations of infant formula manufactured at the company's Georgia, VT plant, live and dead mites were discovered in the finished infant formula product.
FDA sent investigator Thomas Morgan from the agency's Vermont office to investigate on Jan. 24, 2001. A 483 was not issued to the firm.
Morgan noted in the EIR that the mites were first discovered on Jan. 9, 2002, while conducting a microscopic examination for metal fragments. The firm immediately began an investigation to find the source of the mites and determine what product might have been adulterated with mites.
The EIR noted that "the rate of sampling was increased to every 15 minutes," and during that period, the laboratory technician "observed a live arthropod (mite) on the scorch pad used as the filter for this test." The packaging line was then shut down and the can blower filters and trays were cleaned and sanitized. Debris was taken to the laboratory for review and no mites were found.
WNI did not know the source of the mites or how they got into the cans. The firm sampled 125 empty cans when they arrived at the warehouse and no mites were found. The cans were subsequently released for manufacturing on Jan. 10. "The laboratory funnel, container and pads utilized to perform the metal examination did not reveal any mites," the EIR stated.
WNI instituted a plan on Jan 16, to allow production while QA continued to look for mites. In the meantime, the top two layers of cans including the slip sheets and top frames of each pallet were removed and discarded before the cans were brought to the packaging line. The can blower was cleaned every two hours including an alcohol rinse and the debris from the can blower was inspected for mites as well. Additionally, formula was sampled at the packaging line every 15 minutes.
The top frames from seven pallets of cans were tested for mites and, on Jan. 16, one live mite and one dead mite were found on the top frame while packing product.
Additional mites were found on Jan. 17 in finished products and the plant voluntarily shut down all of their manufacturing. Wyeth also stopped distribution and started holding infant formula in warehouses, cargo containers and aboard ships. The oldest can date that tested positive was Dec. 4, 2001.
The EIR stated that "WNI instituted a Crisis Management Team to tabulate and review the data and information they had been collecting regarding the mite adulteration. When WNI graphed the incidence of mites detected they determined that the mites in their finished product was not a function of can manufacturing dates, but a function of a localized contamination of the pallets and top frames used to transport the cans."
A team from the Georgia, VT, plant visited Wyeth's can supplier in Baltimore, MD, on Jan. 25, and took top frames and bagged them into large clean sheets of paper and collected the debris. They sampled the slip sheets between the layers of cans and empty cans as well. Mites were found collected from top frames and sent to a laboratory for identification.
The firm subsequently traced back 11 trailer loads of cans from Dec. 21, 2001 to Jan. 11, 2002, according to the EIR.
The firm instituted measures to "heat treat" empty cans in order to kill any mites that were stored in one of their warehouses awaiting product. WNI said it also planned to replace the wooden pallets with plastic pallets because they are easier to clean, Morgan noted in the EIR.
WNI also stated that it would destroy all product manufactured between Jan. 7 and Jan. 17, 2002. "When all the returned product is consolidated WNI will contact the FDA about the method of destruction and the final can count," Morgan wrote in the EIR.
The final report from QA stated that 25 mites were detected in seven batches of formula manufactured during the period of January 7-17, 2002. One mite was detected in a batch manufactured on Dec. 23, 2001. WNI believes that this single mite was in all probability the result of cross contamination from previously tested batches containing a high concentration of mites." The report concluded that testing of 1,146 cans sampled from seven batches manufactured between Dec. 23, 2001 and Jan. 7, 2002 yielded no mites. A Wyeth spokeswoman said the firm would have no comment on the mite incident and audit.
Wyeth Nutritionals, Georgia, VT, 1/24, 25, 28, 30, 31, 2/6, 15/02, Doc. 1093813M, $5.00 plus retrieval.
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