When the FDA spent 9 days going over the Canton Laboratories active pharmaceutical ingredient (API) facility in Vadodara, India, last year, inspectors said employees were not getting equipment clean enough between batches to prevent cross contamination. The company's certificates of analysis had been showing its APIs were within limits for microbial and metal content, but there was a problem with those tests: They never occurred. The company was just making up data and then shipping out products, the FDA says.
A Feb. 27 warning letter posted this week on the FDA website says: "Multiple personnel confirmed that your firm did not perform the microbial tests reported on the CoAs." Additionally, inspectors could find only 38 results for Atomic Absorption Spectrophotometer (AAS) testing when 400 AAS tests were reportedly done. The FDA said the fact that analysts could access and delete data was a huge problem.
The API maker promised it would retrain employees and fix the issues, but the FDA said it made the same claims when the FDA inspected the plant 5 years ago. The agency said it wanted a report on all of the products shipped to the U.S. that might be affected by the quality breaches. It wants detailed reports on how the company will upgrade systems and processes and assure its APIs are safe and effective.
Falsifying drug analytics has been a recurring theme in facility inspections the FDA has been doing in India. The agency leveled similar complaints against drugmaker USV in Mumbai last month. It has also factored in to the long-running problems at India's Ranbaxy Laboratories and at Wockhardt, two Indian companies that have had plants banned from shipping to the U.S. in the last 10 months. It was also noted in a warning letter issued last year to an Indian facility owned by Germany's Fresenius Kabi.
Quality, or in too many cases the lack of it, was a primary theme for FDA Commissioner Margaret Hamburg during meetings in India last month with government and industry officials. While she noted that there were many top-notch drug producers in the country, she said that given India's importance to the global supply chain, regulators there need to get in line with international standards and expectations.
- here's the warning letter