Care-Tech agrees to stop distributing OTC antimicrobial drugs
This article was originally published in The Gold Sheet
Executive Summary
St. Louis-based Care-Tech Laboratories Inc. and its principal officers have agreed to stop manufacturing and distributing their line of over-the-counter antimicrobial drugs under the terms of a recently signed consent decree with FDA until certain problems are remedied. Sixteen antimicrobial drugs used to treat and prevent topical infection are affected by the action. FDA inspectors found that Care-Tech violated numerous provisions of the cGMP regulations that direct how antimicrobial drugs are made. Additionally, inspectors found that the products did not conform to any applicable regulations for OTC drug products and did not undergo FDA review, and therefore are considered unapproved drug products. "FDA is concerned about Care-Tech's products because they lack FDA approval, do not conform to any applicable over-the-counter monograph, and are not appropriately manufactured," said Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. Care-Tech products are sold online and through telephone orders to hospitals, nursing homes and other health care facilities. The firm has had a relatively clean safety record and has not had any problems since 2000, when its Techni-Care antiseptic was recalled due to microbial contamination (see 1"The Gold Sheet," March 2001)
You may also be interested in...
DRUG RECALL DATA FOR 2000
...show the influence of adverse FDA inspection and sample findings. A majority of recalls conducted recently have been prompted by FDA rather than manufacturer quality systems – a disturbing trend from the agency’s point of view. FDA compliance concerns are reflected, in particular, in a significant number of recalls during 2000 involving the potential for product contamination from faulty aseptic processing and the mishandling of beta-lactam products. Six contamination-related recalls drew a Class I rating as did nine involving products with unapproved claims or ingredients. Error and accident reports shed light on manufacturing problems biologic producers are having, but only a limited percentage result in recalls. [An eight-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 2000 begins on p. 12.]
Fujifilm Demonstrates Health Specialism With European HealthTech Spinout
From X-ray film in 1936 to the world’s first digital X-ray system in 1983, Fujifilm has a long heritage in medical diagnostics.
Financing Quarterly Statistics, Q1 2024
During Q1, biopharmas brought in an aggregate $30.1bn in financing and device company fundraising totaled $2.8bn; while in vitro diagnostic firms and research tools players raised $724m.