The speculation over observations by US Food and Drug Administration (FDA) against generic drugmaker Wockhardt's Morton Grove facility in Illinois was put to rest with the regulator specifying 12 observations.
The FDA has issued the company a Form 483, which is a letter that details unsatisfactory results of manufacturing facilities made by FDA inspectors for compliance with the current good manufacturing practices (cGMP).
FDA officials carried out the inspection at the company's US unit between January 22 and March 26. While the company's top management, during the earnings call on May 27, said that the observations made may not be "very negative", the document provided on the agency's website pointed out too many lapses in the production process. The facility accounts for over 50% of its sales in the US.
The document sent to Sivakumar Chinniah, vice-president, operations and supply chain, Morton Grove Pharmaceuticals, Inc, by FDA investigator Brian D Nicholson, said, "The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Your firm's quality unit is not fully monitoring quality systems designed to assure the safety and quality of drug products manufactured by your firm."
This failure is evidenced by the continued uncontrolled use of "trial" injections during chromatographic testing to release drug products and monitor stability of drug products after this practice was cited in warning letters issued to two other Wockhardt facilities, it added
The FDA had last year issued import ban on two of Wockhardt's facilities in Waluj and Chikalthana in Maharashtra.
Among other observations raised by FDA on the Illinois plant are also that the laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, drug product containers, in-process materials, and drug products conform to appropriate standards of identity, strength, quality and purity.
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation properly identified to show the specific component, in-process material, lot tested, and drug product tested, it said.
The document also said there was is failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. The quality control unit also lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
The last four lapses mentioned in the document said that time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. "Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition. Good manufacturing practice (GMP) training is not conducted to assure that employees remain familiar with cGMP requirements applicable to them. Also, production personnel were not practicing good sanitation and health habits," the document said.