UK Regulator Recalls Progesterone Produced By India-Based Akums Drugs And Pharmaceuticals

JD
Jones Day

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
The Statement of Non-Compliance with GMP published on the EudraGMP website noted that one critical and three major deficiencies were uncovered during the inspection.
United Kingdom Food, Drugs, Healthcare, Life Sciences

The UK's Medicines and Healthcare Products Agency has ordered India's Akums Drugs and Pharmaceuticals to recall four batches of progesterone produced at its Hardiwar facility due to critical deficiencies uncovered during an April 2016 inspection. The Statement of Non-Compliance with GMP published on the EudraGMP website noted that one critical and three major deficiencies were uncovered during the inspection. The critical deficiency was for lack of sterility assurance, and the major deficiencies were for inadequate control and validation of sterilization, deficiencies across all aspects of the quality management system, and lack of a robust environmental monitoring program. Thirteen other deficiencies covering all aspects of GMP were recorded but not formally reported so as not to distract from the critical and major deficiencies.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More