• Huge Batch of 483s to Pharmaceutical Compounders Show Sterility Concerns Endemic

    A crackdown on pharmaceutical compounders is growing ever wider, with the US Food and Drug Administration (FDA) adding another 15 inspection deficiency reports (Form 483s) to its website outlining a string of sterility problems increasingly seen as endemic throughout the industry. In the wake of similar problems uncovered in late 2012-and a surge of interest from the media-FDA has started to post all Form 483 reports related to compounding pharmacies on its website. Thos...
  • Pharmaceutical Company's Regulatory Missteps Tempt Shareholder Legal Action

    • 18 March 2013
    Generics pharmaceutical manufacturer Impax Laboratories hasn't had an easy last two weeks. On 4 March 2013, it announced that the US Food and Drug Administration (FDA) had, after conducting an inspection at its California Facility, determined that the facility had 12 deficiencies, and issued it a Form 483 . Those deficiencies sent the firm's shares plunging . Then, on 15 March 2013, FDA announced it would withdraw approval for the company's generic equivalent of bupro...
  • Sterility Violations Form Basis of FDA Warning Letter to Novo Nordisk

    Life sciences manufacturer Novo Nordisk has been sent a Warning Letter from the US Food and Drug Administration for what regulators said were "significant" deficiencies found at the company's Bagsvaerd, Denmark facility. FDA officials said they were particularly concerned about current good manufacturing practice (CGMP) violations found at the firm, which included practice deviations that could have potentially led to product being manufactured under non-sterile condit...
  • Warning Letter Claims South Korean Device Company Failed to Implement Promised Changes

    A South Korean medical device company is at the receiving end of a particularly blunt warning letter in which US regulators accuse the company of fixing almost none of the problems they found during a 2010 inspection. The 26 November 2012 letter to Seoul-based Sometech Incorporated, manufacturer of medical imaging equipment and high-frequency surgical instruments, references an April 2012 inspection by the US Food and Drug Administration (FDA). During that inspectio...
  • Chinese Firm Used White Out to Change Regulatory Records, FDA Says

    Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations. The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In ...
  • FDA Inspectors Find Insects, Animal, Contamination at Compounding Facility

    Inspectors with the US Food and Drug Administration (FDA) have found microbial contamination, unevaluated adverse event reports, ongoing water leaks, contaminated hoods, multi-colored residues, insects and at least one bird in a compounding pharmacy owned by the same company now associated with a massive outbreak of fungal meningitis. The observations-made in a FDA Form 483 inspection report of compounder Ameridose's Westborough, MA facility-closely track a 483 release...
  • Troubling Sterility Lapses Found at Compounding Facility

    The US Food and Drug Administration (FDA) has identified a number of troubling lapses in good manufacturing practices at the New England Compounding Center ( NECC ), the Massachusetts-based pharmaceutical compounding facility now linked to a massive outbreak of fungal meningitis, after an inspection revealed widespread and unaddressed sterility problems. Regulators released a Form 483 , a form FDA uses to list potential violations of the Federal Food, Drug and Cosmet...
  • Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

    The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority but critics have derided as the regulation of the practice of medicine. A 24 September warning letter to Texas-based CellTex Therapeutics Corporation references the firm's use of adipose tissue (lipoaspirate) recovered from donors, which is then isolated and cultured into adi...
  • FDA Transitioning to Tablet-Based Inspection System for Food, Pharmaceutical Facilities

    The US Food and Drug Administration (FDA) is laying the groundwork to eventually transition away from the use of paper-based inspection journals in favor of digital-based tablet inspection aids, say several FDA officials. The agency, including FDA Commissioner Margaret Hamburg, has recently begun to tout its use of a new, Windows-based rugged tablet computer for use during egg  farm inspections. An FDA spokeswoman, Patricia El-Hinnawy, told Regulatory Focus that ...
  • Feature ArticlesFeature Articles

    Pitfalls in Good Clinical Practice

    A pitfall can be defined as a potential and usually unanticipated disaster or difficulty. 1 When we perform clinical studies we try to anticipate unforeseen pitfalls before they arise. However, other occurrences are clearly foreseeable, yet we permit them-or cause them-to happen. Good Clinical Practice (GCP) refers to international standards of quality for the performance of clinical studies with human subjects. These standards aim to ensure the data generated are h...
  • Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit

    In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the US Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs. Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder l...
  • FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products

    The US Food and Drug Administration (FDA) announced in a Federal Register posting on 18 May it has not yet come to a conclusion regarding a Citizen Petition request to stop the issuance of national drug codes (NDCs) for products lacking either a New Drug Application (NDA)or Abbreviated New Drug Application (ANDA) number. The Citizen Petition was filed in December 2011 by Dr. S. Albert Edwards, RAC, who requested FDA phase out the use of NDCs over a three-year period. C...