According to a report filed on the European Medicines Agency’s (EMA) EudraGMP database last week, ANSM inspectors who visited the firm’s facility in Dongying City in December observed 10 deviations from good manufacturing practices (GMP) standards.
The ANSM inspectors said Dongying had used seven batches of out of specification (OOS) crude heparin to make active pharmaceutical ingredients (API) between 2014 and 2015, which they said indicated a “misunderstanding of the basic GMP principles.”
They also said the firm had not evaluated raw material suppliers sufficiently, specifically that it failed to store delivery documents, test crude heparin or investigate out of specification results identified by a contract analysis laboratory.
The French team also suggested “PCR results of Crude Heparin showing the presence of ruminant DNA received from approved suppliers were manipulated. There was no evidence that the samples retested came from the same batch tested initially.”
They issued a letter of noncompliance and suggested the EMA revoke Dongying’s GMP certificate – issued by Polish inspectors (GIF-IW-N-4022/68/13) – and called on the consider ordering a recall of heparin products made using the suspect API.
ANSM also called on the EDQM to suspend CEP 2005-258 for Enoxaparin sodium produced by the firm.
According to Dongying's website, the firm passed a US Food and Drug Administration (FDA) inspection in 2013 and was been cleared to supply heparin sodium and enoxaparin sodium APIs by Mexican authorities in 2014.
The firm did not respond to a request for comment.