Indian Drugmaker to FDA: Dance Festival to Blame for Cleaning Lapses
The US Food and Drug Administration (FDA) last month warned Indian drugmaker Centurion Laboratories over good manufacturing practice (GMP) violations observed at the company’s Gujarat facility last October.During the five-day inspection, the FDA investigator observed multiple deficiencies related to laboratory records, computer system controls and cleaning and maintenance. Due to the deficiencies observed during the inspection, FDA placed Centurion on import alert on 11 March 2019.
However, what stands out in the warning letter is the company’s explanation of why some of its equipment was not cleaned and maintained according to its own written procedures.
According to FDA, the investigator found equipment used to make at least four products for US distribution that was marked “cleaned” despite the presence of visible product build-up and multiple holes in its air filter.
“A memo provided during the inspection stated these cleaning and equipment maintenance deficiencies were because of a shortage in manpower related to a nine-day dancing festival and government holiday,” FDA writes.
The investigator also found multiple trash bags containing torn up documents including stability study data, analytical testing sheets, analysis calculations and release forms.
FDA says that some of the documents contained out-of-specification results for certain batches of products that were officially recorded as within specification. The investigator also found blank stability study forms that were pre-signed and approved by the quality unit.
According to the warning letter, Centurion said the torn documents were from scale-up batches and were destroyed “so as ‘not to create confusion in the mind of the investigator,’” but did not explain the discrepancies between the torn documents and the official records kept by the quality control unit.
Additionally, FDA says Centurion failed to establish appropriate controls over its quality control computer systems and allowed multiple employees, including quality control analysts, a company executive and a software service provider to share a single username and password for the its high-performance chromatography systems.
In response to the warning letter, FDA says Centurion must develop a comprehensive plan to evaluate its cleaning operations for all its equipment used to manufacture more than one product and address its data integrity issues.
Warning Letter