Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority

Regulatory NewsRegulatory News | 12 August 2016 |  By 

A lack of quality assurance (QA) oversight, a refusal of an inspection by the US Food and Drug Administration (FDA) and a failure to commit to any corrective actions regarding current good manufacturing practice (CGMP) violations observed on an FDA inspection landed a Chinese company an FDA warning letter, and a statement of non-compliance and a ban for two Indian companies recently.

The FDA warning letter, dated 26 July for Tianjan, China-based Concept Products Limited, criticized the company for not committing “to any corrective actions regarding the CGMP violations observed” during an inspection from 3-5 August 2015.

The letter did not delve into too much detail on the five violations, noting instead some more basic problems, like not having, for each batch of drug product, “appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release.”

Meanwhile, on Thursday, FDA added Laxachem Organics Pvt. Ltd.’s Amravati, India-based manufacturing site to its list of companies that refused an FDA inspection. Laxachem says on its website that it produces 14 active pharmaceutical ingredients, including simethicone.

And for Hyderabad, India-based Artemis Biotech, which produces multiple products for the EU market, a German competent authority, identified as Landesamt für soziale Dienste Schleswig-Holstein in the EudraGMDP report released Friday, made 35 observations in its June inspection, including five categorized as major deficiencies, meaning “potentially leading to a risk to the human and veterinary patient when using active pharmaceutical ingredients manufactured at the inspected site.”

“The installation and execution of an Enterprise Resource Planning System, hosting GMP relevant data but outside of the quality management system, demonstrated a lack of QA oversight,” the statement of noncompliance says. ”Repackaging operations were conducted without any documentation and QA approval. The issuance of labels for raw materials and APIs was found inadequately controlled.”

Within the instrumental laboratory, the German officials also identified violations of “basic principles on data integrity, i.e. manual integration without justification and QA oversight. The Company’s approach on the validation of computerised systems (Shimadzu LabSolutions) was considered as not in compliance with the requirements.”

This inspection was carried out as part of the EDQM inspection program. The statement also says Artemis should not be approved in any new/ongoing applications and each involved national competent authority (the company produces Fumagillin (antibiotic manufactured from fermentation) for the French market) should evaluate if the supplier should be removed from existing marketing applications.


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