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  • Regulatory NewsRegulatory News

    FDA Warns Swedish IVD Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II  in vitro  diagnostic (IVD) devices. The warning, following an inspection last January, features at least five violations, including one related to the company’s decision to not recall an assay used to detect anti-nuclear antibodies after receiving complaints of a higher incidence of false p...
  • Regulatory NewsRegulatory News

    WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

    A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement. "At the moment, there is no alternative levonorgestrel API which has been prequalified," WHO said Wednesday. When an API is prequalified by WHO, it can be used for the manufacture of finished pharmaceuti...
  • Regulatory NewsRegulatory News

    CDRH Lays Out Guidance Plans for FY 2017

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017. The final guidance documents on the so-called “A-list” deal with some hot-button issues, including the use of real world evidence (which is also included on CDRH’s top 10 list of science priorities for 2017) to support medical device regulato...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese Drug Manufacturer for Limiting Inspection, Systemic Data Manipulation

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Beijing Taiyang Pharmaceutical Industry Co. on 19 October after the company limited FDA’s ability to conduct an inspection and manipulated manufacturing data. The warning letter follows FDA adding the company to two import alert lists in April, effectively halting its ability to ship products to the US. Barred Entry to Warehouse On 16 November 2015, FDA investigators observed throu...
  • Regulatory NewsRegulatory News

    French Regulators Raise Serious Concerns With Indian API Manufacturer

    France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries. In an inspection from 20 August, the French regulators uncovered significant deficiencies linked to “the vast majority of inspected areas” at Nandu’s Hubli, India site. In particular, the inspectors highli...
  • Regulatory NewsRegulatory News

    FDA Warning Letter Details Serious Violations by another Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released another Warning Letter for an Active Pharmaceutical Ingredient (API) and drug manufacturer in India with a series of severe findings. The most recent letter sent to Gujarat, India-based Pan Drugs, which is already barred from supplying drugs and APIs to the US, follows the identification of more Current Good Manufacturing Practices (CGMP) violations by FDA inspectors, including data integrity issues, as well a...
  • New Warning Letters to Indian Manufacturers Again Find CGMP Violations, Falsified Test Results

    Another batch of Warning Letters made public by the US Food and Drug Administration (FDA) has brought still more negative attention toward Indian pharmaceutical manufacturers, with issues that mirror recent letters and include falsification of records and failure to assure product sterility. Background Indian manufacturers have been the focus of intense scrutiny in recent months following a major court case involving Indian manufacturer Ranbaxy, in which it pleaded gu...
  • FDA Cracks Down on Indian Manufacturers, Citing New FDASIA Authority and Egregious Violations

    In the wake of a disturbing regulatory investigation against Indian manufacturer Ranbaxy, in which regulators determined that the company had routinely falsified and altered testing results-determinations that later resulted in a massive $500 million fine against the company, the largest in history-the US Food and Drug Administration appears to be cracking down hard on other Indian manufacturers for similar discrepancies. The Start of a Crackdown? The first hint of th...
  • Warning Letter to Wockhardt Details Extraordinary Failures, Efforts to Deceive FDA Inspectors

    Indian pharmaceutical manufacturer Wockhardt has not had an easy few months. A March 2013 inspection by the US Food and Drug Administration (FDA) resulted in an import alert for products manufactured at the company's Waluj, Aurangabad facility, and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a massive recall for products manufactured at the same facility. Clearly, something at the facility was amiss-something confirmed by the India Times ...
  • Investigation of Indian Manufacturer Finds Deficient Testing Practices, Falsified Records

    A Warning Letter sent by the US Food and Drug Administration (FDA) to an Indian pharmaceutical manufacturer alleges that the company routinely repeated tests when initial testing did not give it the desired results and, in at least one case, improperly back-dated results. The 28 May 2013 Warning Letter references two inspections conducted by FDA, one in November 2012 of RPG Life Sciences' Ankleshwar, Mumbai facility and the other a January 2013 inspection of its Navi, ...
  • New FDA Guidance Recommends Use of Quality Agreements to Define Contract Responsibilities

    The US Food and Drug Administration (FDA) has released a new draft guidance regarding contract manufacturing arrangements, establishing the responsibilities of each entity involved in the manufacture of a pharmaceutical product in adherence to current good manufacturing practices (CGMPs). Background The draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements , comes just as FDA has been identifying lapses in contract manufacturing arrangem...
  • China Sets Deadlines for Drug GMP Implementation

    China's State Food and Drug Administration (SFDA), the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health issued on 21 December 2012, a joint notice to the provinces and municipalities setting forth deadlines for implementation of the revised good manufacturing practices (GMPs) by the pharmaceutical industry.  Injectable drug manufacturers must implement the revised GMPs by 1 January 2014, a...