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Centurian Labs gets US FDA warning for various lapses

FDA asks the company to provide corrective actions and preventative actions plan to the agency

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Gujarat-based Centurion Laboratories Pvt Ltd has been issued a warning letter after US Food and Drug Administration (FDA) inspectors found deviation in data integrity at its plant.

In the warning letter, dated May 4, the FDA inspectors found failure to ensure laboratory records, including complete data necessary to ensure compliance with established specifications and standards, a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures during its inspection period October 22-26, 2018.

Established in 2006, the unlisted company is a producer and exporter of pharmaceutical drugs such as cardiovascular, anti-tuberculosis, psychiatric products, among others.

The FDA inspector observed torn documents of stability study data, analytical testing sheets, analysis calculations and release forms that were placed into clear trash bags. Stability study documents for three batches of tablets were salvaged from the trash and compared to the official and approved records. Out-of-specification (OOS) results were among the data found; however, the official results were recorded as within specification. The FDA inspector observed that blank stability study forms were prepared, pre-signed and approved by the quality unit before recording the test data.

FDA asked the company to provide corrective actions and preventative actions plan to the agency.

According to the regulator, the company's laboratory equipment used for batch release and stability testing purposes did not have appropriate controls and procedures to ensure changes were only made by the authorised personnel.

"For example, quality control analysts, a company executive and your software service provider - all shared username and password for your high-performance chromatography systems. In addition, analysts were authorised full system administrator privileges. These privileges allowed modification and deletion of data files and folders. Furthermore, you lacked a procedure for controlling staff use and privileges of your computer systems," FDA said in its letter.

FDA recommended that the company perform data integrity remediation and provide a detailed investigation protocol, interviews with current and former employees, an assessment of data integrity deficiencies and a retrospective evaluation of testing data.

Additionally, during the inspection, FDA investigator observed that equipment used to manufacture more than one product was inadequately maintained and cleaned. The equipment was found to have visible product build-up inside. Furthermore, the air filter of the equipment was damaged with multiple holes. This equipment was used to manufacture finished drug products shipped to the United States, the agency noted.

"Additionally, 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. Inadequately cleaned and maintained equipment can lead to cross-contamination and variability of drug products. Additionally, you did not perform a risk assessment of drug products distributed to the US market that were manufactured on multi-use equipment which lacked adequate cleaning and maintenance," the FDA further said.

The agency asked the company to provide a plan to evaluate its cleaning procedures and validation studies, a scientific rationale for its cleaning validation strategy, a summary of updates to its cleaning validation protocol, a summary of its standard operating procedures for verification and validation of cleaning procedures and a retrospective risk assessment.

"Until you correct all violations completely and we confirm your compliance with complete good manufacturing practices (CGMP), FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer," the regulator said. FDA placed the firm on Import Alert 66-40 on March 11, 2019.

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