FDA Warns Chinese Crude Heparin Manufacturer, 2 Drugmakers in India
The US Food and Drug Administration (FDA) on Tuesday released three warning letters sent earlier this month to China-based active pharmaceutical ingredient (API) manufacturer Yibin Lihao Biotechnical Co., Ltd, and India-based drugmaker JHS Svendgaard Hygiene Products Ltd. and contract manufacturer Essnd Global.For Yibin Lihao, which was placed on import alert on 15 January, the company told FDA inspectors that the Yibin-based site had not produced crude heparin for purification into finished API “for months,” but in a walkthrough of the site’s warehouse, inspectors found “two batches of crude heparin manufactured just a few days before the FDA inspection.”
FDA’s investigator also observed “numerous records on the floor, desks, and cabinets of the Quality Assurance (QA) Office on the third floor of the office building. Some of these records included batch production records for heparin,” the letter from 13 February says.
The firm also did not have the complete batch records for heparin produced last June and July. "Traceability of crude heparin is a critical part of managing quality. You must ensure that a complete contemporaneous record of each batch of drug manufactured is retained for CGMP purposes. Your system for managing quality is inadequate and calls into question the traceability of all drugs, including crude heparin. manufactured at your facility," FDA added.
In 2018, Yibin also received a statement of noncompliance with good manufacturing practices (GMP) from the Italian Medicines Agency.
Concerns over Chinese heparin manufacturers have lingered for more than a decade as in 2007 and 2008, adulterated heparin sourced from China led to the deaths of more than 100 Americans. FDA previously warned another crude heparin manufacturer in 2016.
Meanwhile, FDA’s warning letter to India’s JHS Svendgaard Hygiene Products, which was placed on import alert on 2 January, notes how the firm lacked adequate testing for incoming API and relied on its suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation.
The firm also did not provide sufficient information regarding the validation or verification of its test methods, FDA said in a 13 February letter.
For contract manufacturer Essnd, which was placed on import alert on 31 January, FDA said the firm released drug product without adequate testing, including identity and strength testing of the active ingredient.
“In addition, you released your drug product without appropriate testing for total aerobic microbial count and objectionable microorganisms,” the agency’s 14 February letter said.
FDA also said the firm lacks an adequate quality unit and “could not provide procedures for stability studies, out-of-specification investigations, product release, and deviation investigations.”
Yibin Lihao Bio-technical Co., Ltd.
JHS Svendgaard Hygiene Products Ltd
Essnd Global