Following an inspection at the company’s manufacturing facility in Taizhou City, Zhejiang Province, last March, the US Food and Drug Administration (FDA) has issued Zhejiang Hisun a warning citing a number of deviations from current good manufacturing practice (cGMP).
According to the letter, the firm failed to “prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data,” and instead relied on incomplete records to evaluate the quality of drugs.
Furthermore, the Agency continued: “We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs.”
The API maker was also cited as having deleted original data and disabled the audit trail at the facility.
“Because the audit trail was disabled, neither your quality unit nor your laboratory staff could demonstrate that records for these batches included complete and unaltered data.”
Alongside data issues, the company failed to conduct appropriate microbiological testing on API batches.
“We observed that all 14 culture media plates in incubator #6 were dried out and cracked, which compromised microbial growth promotion and accurate enumeration. These plates were used to test multiple API batches,” the letter said.
Zhejiang Hisun claims, in the letter, that deformed glass plates had caused the media to crack, and the batches were retested.
EU hits another Chinese API maker
The warning is the latest for China’s API industry. This month, the French National Agency for Medicines and Health Products Safety (AFMPS) issued a certificate of non-compliance to Minsheng Group ShaoXing Pharmaceutical at its site also in the Zhejiang Province.
“Overall, 18 deficiencies were observed during the inspection, including 2 Critical and 4 Major deficiencies,” the certificate said.
These included the falsification of source of API (Thiamphenicol): repackaging, relabeling and selling the purchased API from a non-GMP company (Zhejiang Runkang Pharmaceutical Co.Ltd.) as if manufactured in-house. A lack of audit trail was also cited.
And last April the FDA sent cancer-drug API maker Yunnan Hande Bio-Tech a letter after observing data manipulation at its plant in Kunming, Yunnan Province.