FDA warns Chinese drugmaker for refusing access during inspection, Indian firm for data integrity lapses
Regulatory News | 20 November 2024 |
The US Food and Drug Administration (FDA) has warned Chinese drugmaker Tianjib Darentang Jingwanhong Pharmaceutical for limiting investigators’ access to its facility and records and restricted photography during a recent inspection.
In a separate compliance action, Unexo Lifesciences in New Delhi, India was warned for manipulating data for its transdermal patches. Both warning letters were posted to FDA’s website on 19 November.
Tianjin Darentang Jingwanhong
Tianjin Darentang makes Chinese herbal medicines, proprietary Chinese medicines, chemical raw materials and preparations, and pharmaceutical products, according to its website.
FDA said the firm denied investigators access to full production and batch records during an inspection in March 2024, including equipment qualification records. While the company had the documents translated, they were “unreasonably redacted for the total net weights of components in the production batch record and processing parameters in the process validation report, respectively.”
Inspectors were also blocked from taking photos of filling machines, which were deemed “dirty” and in a “state of disrepair.”
FDA said the company also refused entry into the manufacturing rooms. “When our inspection team explained that failure to allow FDA to access and evaluate manufacturing equipment and operations would be documented as a refusal, you acknowledged the refusal.”
Investigators also found a failure to adequately clean equipment used to make topical drugs. Residue was observed on filling machines which also had several missing screws and broken motor housing panel.
The company also failed to perform forced degradation studies to demonstrate the drug’s stability.
Products were placed on an import alert on 20 August 2024. The company has 15 days to respond.
Unexo Lifesciences
Investigators found similar problems with respect to Unexo’s handling of production records. In one instance, batch production records were torn and found in plastic bags on the rooftop. The company’s executive management admitted to not having all the batch records for the released drug products and said that batch production records were “retrospectively prepared” to provide to the investigators.
In another case, the company lacked raw data to support the product’s final release. Some of the missing data included the patches’ peel strength. The company “provided no explanation when asked how you released the batch without the data,” states the letter.
Another problem was the failure to maintain control over its computer systems. Its QC analyst “had the ability to manipulate results, dates, and images of in-house and vendor stamp approvals on component certificate of analyses (COAs) from third-party contract laboratories.”
Investigators also found “unclean air conditioner vents above production areas” which exposed drug products to air flowing from the unclean vents.
FDA investigators were also unable to access the firm’s sole computer, which was at home with an employee.
The company has 15 days to resolve the issues identified in the warning letter.
Tianjin Darentang; Unexo
In a separate compliance action, Unexo Lifesciences in New Delhi, India was warned for manipulating data for its transdermal patches. Both warning letters were posted to FDA’s website on 19 November.
Tianjin Darentang Jingwanhong
Tianjin Darentang makes Chinese herbal medicines, proprietary Chinese medicines, chemical raw materials and preparations, and pharmaceutical products, according to its website.
FDA said the firm denied investigators access to full production and batch records during an inspection in March 2024, including equipment qualification records. While the company had the documents translated, they were “unreasonably redacted for the total net weights of components in the production batch record and processing parameters in the process validation report, respectively.”
Inspectors were also blocked from taking photos of filling machines, which were deemed “dirty” and in a “state of disrepair.”
FDA said the company also refused entry into the manufacturing rooms. “When our inspection team explained that failure to allow FDA to access and evaluate manufacturing equipment and operations would be documented as a refusal, you acknowledged the refusal.”
Investigators also found a failure to adequately clean equipment used to make topical drugs. Residue was observed on filling machines which also had several missing screws and broken motor housing panel.
The company also failed to perform forced degradation studies to demonstrate the drug’s stability.
Products were placed on an import alert on 20 August 2024. The company has 15 days to respond.
Unexo Lifesciences
Investigators found similar problems with respect to Unexo’s handling of production records. In one instance, batch production records were torn and found in plastic bags on the rooftop. The company’s executive management admitted to not having all the batch records for the released drug products and said that batch production records were “retrospectively prepared” to provide to the investigators.
In another case, the company lacked raw data to support the product’s final release. Some of the missing data included the patches’ peel strength. The company “provided no explanation when asked how you released the batch without the data,” states the letter.
Another problem was the failure to maintain control over its computer systems. Its QC analyst “had the ability to manipulate results, dates, and images of in-house and vendor stamp approvals on component certificate of analyses (COAs) from third-party contract laboratories.”
Investigators also found “unclean air conditioner vents above production areas” which exposed drug products to air flowing from the unclean vents.
FDA investigators were also unable to access the firm’s sole computer, which was at home with an employee.
The company has 15 days to resolve the issues identified in the warning letter.
Tianjin Darentang; Unexo
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