Major USFDA warning Letters observation from 2000

The United States Food and Drug Administration (FDA) defines a Warning Letter as

“…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.

On a cold Sunday afternoon in January, Peter E. Baker (Since 2008, Peter has audited 110 facilities with 36 other inspectors. mail: peter.e.baker@fda.hhs.gov) is in Toansa village, Punjab. He is at the gates of the showcase plant of Ranbaxy, Indias leading pharmaceutical company, some 160 km from Chandigarh airport. This plant makes the active ingredients that go into tablets. The security guard seems unaware not only about who Baker is, but also about the organisation he represents – the US Food and Drug Administration (FDA). He contacts the plant supervisor.

Drug industry executives know Baker only too well. A senior executive at a Mumbai-based pharma major says of Baker, a veteran investigator with the FDA: “Not only does he catch you when you least expect him to, but his style of functioning is unique. He will look at the most unexpected places in the plant… If he finds anything wrong, he will doubt everything, and youve had it.”

Last 10 Firms Inspected

Date of Last Inspection	Firm Inspected
2014-11-21	Dr. Reddy’s Laboratories Limited CTO VI
2014-10-17	Ipca Laboratories LTd
2014-08-29	Sandoz Private Limited
2014-08-09	Aarti Drugs Limited
2014-07-18	Ipca Laboratories, Ltd.
2014-07-01	Apotex Research Private Limited
2014-06-12	Akorn India PVT
2014-05-13	Micro Lab Limited
2014-03-22	Hospira Healthcare India Pvt Ltd
2014-03-10	Sharp Global Limited

Reference sourced from: http://fdazilla.com/ 

Stories doing the rounds in pharma circles tell of dustbins being checked at one company, and urinals in another. The executive adds: “We look into every minute detail now, but still just hope and pray that nothing ever goes wrong.” 

A pharma company CEO, who does not want to be named, says: “After I learnt that the Mohali facility of Ranbaxy did not have water heaters in the bathrooms, I checked all our bathrooms in the plant, and to my surprise, we did not have them either. The thought that it could become a point for closure… I immediately had them installed.”

Another pharma company head personally took his team of experts to check urinals and drains in the plant after reading the FDAs observations on Wockhardts factory.