• Regulatory NewsRegulatory News

    FDA Dings Surgical Instrument Manufacturer Over 'Unacceptable' Timelines

    American Contract Systems provided “unacceptable” timelines to correct US Food and Drug Administration (FDA) inspectional citations, according to a new FDA warning letter.   The Pennsylvania-based manufacturer of surgical trays and kits indicated for hospital use drew a total of five significant violations, following the quick turnaround on the warning letter. FDA investigators inspected the firm’s manufacturing facility in Zelienople over the course of two weeks from ...
  • Regulatory NewsRegulatory News

    FDA Warns Korean Drugmaker Over Poor Aseptic Practices, Patchy Lab Records

    South Korea-based Hanlim Pharm Co. drew a US Food and Drug Administration (FDA) warning letter over poor aseptic practices and inadequate processes for documentation, among other violations of good manufacturing practice (GMP). The FDA inspection of the company’s drug manufacturing facility in Gyeonggi-do earlier this year concluded that similar GMP violations had been observed during FDA visits to the site in 2014 and 2016. The repeat observations underscore a need for ...
  • Regulatory NewsRegulatory News

    European Commission Consults on Revised GMPs for Sterile Drugs

    The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...
  • Regulatory NewsRegulatory News

    UK's MHRA: Apotex Site Does Not Comply With GMP Requirements

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant. A statement of non-compliance with good manufacturing practice (GMP) requirements highlighted the site’s non-complaint operations related to non-sterile products, packaging and quality control testing. "Due to the nature of the issues identified, batches not released to market are included in the ...
  • Regulatory NewsRegulatory News

    Lupin Warned by FDA for Deficiencies at Two Facilities

    The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India. Lupin acknowledged receiving the warning letter in a Bombay Stock Exchange filing on 7 November, saying it had responded to nine observations stemming from FDA's inspections and that it will work to address the concerns raised in the warning letter. The warning letter says Lupi...
  • Regulatory NewsRegulatory News

    FDA to Recognize 8 EU Regulators to Conduct GMP Inspections

    The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug ma...
  • Regulatory NewsRegulatory News

    FDA Warns Korean Drugmaker Over Testing, GMP Issues

    The US Food and Drug Administration (FDA) has warned South Korean drugmaker Dasan E&T Co. Ltd. over product testing issues following an inspection of its Gimpo, Kyonggi-do facility in January. In a warning letter released on Monday, FDA says the company failed to adequately test its raw materials and finished products to ensure they conformed to appropriate specifications. "Your firm failed to analyze glycerin raw material from your supplier prior to the quality unit re...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors

    The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May. According to FDA, the firm's management admitted to falsifying analytical test results used to release a lot of its products to the US. In another instance, FDA says the firm reported that a batch of one of its products was within specification ...
  • Regulatory NewsRegulatory News

    EMA and FDA to Begin Sharing Commercially Confidential Information

    Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared. As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information. The a...
  • Regulatory NewsRegulatory News

    ICH Details Pilot Training Programs for 2017

    The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan. The training programs are part of a pilot initiative agreed to at ICH's management committee meeting in Osaka, Japan in November 2016, where members of the management committee launched the year-long pilot and set out criteria for the program. Under the pilot, the ICH Training Subcommittee has partnered with a small group of training p...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese Manufacturer for GMP, Training Issues

    The US Food and Drug Administration (FDA) has warned Chinese manufacturer Foshan Flying Medical Products for testing and validation issues at its Guangdong, China facility. According to Foshan's website, the company manufactures a range of medical products including first aid kits, bandages and over-the-counter (OTC) antiseptics. The warning letter, dated 1 August, follows FDA's four day inspection of Foshan's site last February. The agency also placed the company on im...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: No Manufacturers Have Complied With India's GMP Request (15 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Nine Months After Deadline Passed, No Manufacturers Have Complied With DCGI GMP Request The Drug Controller General of India (DCGI) has repeated his demand for manufacturers to assess the quality of their facilities and submit the resulting reports. DCGI Dr. GN Singh made the original request one year ago, but is yet to receive good manufacturing or laboratory practice...