Pan Drugs is a major India pharmaceutical operation. The company manufactures a range of products, including acetaminophen/paracetamol (pain and fever reducer), guaifenesin (expectorant), and methocarbamol (muscle relaxer).
During a routine Good Manufacturing Practice (GMP) inspection by the U.S. Food and Drug Administration (FDA), the inspectorate found a number of non-compliances with the standards expected of companies who import medications into the U.S. These standards are described in the Code of Federal Regulations.
According to Controlled Environments, among the issues cited by FDA were: gaps and holes in outside walls for piping and air ducts allowing outside contaminants into the building; rust, dirt, lubrication leaks, and exposed insulation material on and around drug manufacturing equipment.
Most interestingly the FDA found evidence of pigeons near production equipment in several areas of the facility. It appeared that the birds entered the building after flying into the factory through holes in the roof.
Internal documentation suggests the company knew of this problem back in the summer of 2014. However, operations were only suspended when it was announced that FDA were coming to inspect the facility.
Due to concerns, the FDA has set an import alert. Before any manufacturing for the U.S. market can resume, FDA has asked Pan Drugs to provide photographic evidence that it has upgraded the facility.
There have been a number of concerns with drugs manufactured in India intended for the U.S. market, as Digital Journal has reported. In one example, from 2014, as part of a seemingly routine inspection of Marck Biosciencies’ plant in Kheda, India, the FDA found mold and rotting frogs close to where medicinal products are prepared.
