FEDERAL AGENTS RAID AMBIX LABS

8 August 1993

US Federal marshals have raided Ambix Laboratories of New Jersey, USA, and a civil complaint has been filed against the company, alleging that its sloppy practices are a threat to the public's health.

The government has asked for an immediate injunction to shut down the company, which makes prescription and over-the-counter creams, gels and liquids, including a hydrocortisone cream that allegedly tested positive for Staphylococcus aureus bacteria.

There have as yet been no reports of illness or injury relating to use of these products, according to the US Food and Drug Administration, but while a recall of the hydrocortisone product has not been ordered, this is not ruled out. In the complaint, Ambix is charged with repeatedly ignoring FDA warnings, the first of which came in 1976 and was followed by a further 14. Laboratory equipment has been found to be poorly maintained, tampering of company records is suspected and conditions at the manufacturing plant are unsatisfactory, according to the complaint.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK





Today's issue

Company Spotlight