Pfizer Receives FDA Warning

In a letter from the FDA made public on February 28, a Pfizer plant in McPherson, KS, was accused of ignoring various complaints and safety procedures.

The plant manufactures sterile injectable drugs, but the FDA said that several products were contaminated with foreign matter, and that the injectable antibiotic vancomycin had been “adulterated” by cardboard pieces. The warning letter noted that the company had failed to take corrective action.

If the supply of Vancomycin were to be reduced in the United States, it could be a blow in the efforts to treat anti-biotic resistant bacteria. 

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According to the letter, issued December 31, 2015, the plant received a complaint about particulate matter in a vial of vancomycin, which the plant determined to be bits of cardboard. The plant also knew that the contamination came from a problem related to how the vial stoppers were handled. However, the letter says, the plant “closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions” on February 28, 2016, of last year, despite receiving another complaint on the February 24 and April 15.

The plant recalled a batch of the drug on May 6, 2016, but the FDA deemed that this action was not enough and came far too late after the initial complaints.

Additionally, particulate matter was found in vials of ketorolac tromethamine injection, which according to the letter was not given a “comprehensive assessment.”

Beyond these, the FDA also warned about the failure to adequately follow procedures designed to prevent microbiological contamination, potentially risking the sterility of the finished drugs. The failures were the result of poor aseptic techniques and poor personnel monitoring.

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In addition to these failures, the FDA also warned that the plant had not established valid in-process specifications, which potentially resulted in distributed products that would not have otherwise been distributed.

Finally, the FDA also wrote that the plant had not adequately controlled rejected materials and had failed to provide “scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.”

The letter calls for the plant to answer and investigate several questions, as well as to improve their manufacturing processes. If the plant does not adequately deal with these demands, the FDA could stop its distribution of certain drugs or even shut down the plant entirely.