US FDA GMP Warnings To OTC Firms In China, South Korea
Executive Summary
Cosmo Bio's response to remote records request shows the South Korea company was marketing an unapproved OTC acne treatment without adequate release or stability testing. In China, Hubei Kangzheng was manufacturing an ophthalmic in a Grade D area without appropriate microbial controls.
You may also be interested in...
FDA Warnings About GMP Violations Aren’t The First For Three US OTC Drug Manufacturers
Ultra Seal, Generitech, and Yusef Manufacturing indicated in responses to FDA inspectors’ findings they weren’t aware of, or capable for complying with some of the requirements imposed on them under FDA regulations for ingredient and product testing and other components of quality control.
The Quality Lowdown: Pandemic Site Evaluation Creativity On Display As COVID Clampdown Returns
With a virtual visit to SciVac in Israel, a belated Revance site inspection in California and two weeks at a Dr. Reddy’s site in India, the US FDA finds ways to overcome travel restrictions in its efforts to oversee drug manufacturing quality.
How Post-Approval GMP Challenges Cooled Novo Nordisk’s Blazing Wegovy Launch
Unrelated US FDA inspection led contract manufacturer to stop filling Wegovy syringes before alternate manufacturing facilities became available.