Cobweb Trips up South Carolina Drugmaker
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches.
According to the June 8 warning letter, the company’s batch production records claimed that an oxygen analyzer was used to get results, but cobwebs between the analyzer and the wall implied it hadn’t been used. When questioned, Trans Ox told investigators that it didn’t use the analyzer, directly contradicting the records.
The company said some of the batch records were actually from a supplier’s certificate of analysis, but many of the values reported didn’t match the CoA, the letter adds.
The FDA also dinged Trans Ox for not having an adequate quality control unit. Company officials were unfamiliar with standard quality control terminology, and essential functions of the unit — such as a review of batch information prior to arriving at a batch disposition decision — weren’t being carried out.
The warning letter follows a Nov. 13 to 20, 2014, inspection of the firm’s West Columbia, S.C., facility that resulted in a Form 483.
In its response to the 483, Trans Ox claimed it had created policies and procedures for batch production and quality control, and had appointed a compliance and quality control officer, but no details on training were provided and there was no mention of retrospective review of previously released batches — a step the FDA says is essential to seeing if they met purity specifications.
The FDA urged the company to hire an outside consultant to help bring it into compliance with cGMPs. Trans Ox must also submit a plan detailing corrective actions it will take.
Trans Ox could not be reached for comment by press time.
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