FDA has issued warning letters to two foreign-based aseptic ophthalmic firms citing a strikingly similar litany of problems with procedures and practices designed to prevent microbial contamination.
The warning letters, publicly released by FDA on August 31, were issued to Stericon Pharma in Bangalore, India and Laboratorios L.O. Oftalmi in Caracas, Venezuela. The letters were issued to the firms on August 23 and May 12, respectively, based on inspections completed in March.
Both letters indicate that FDA will refuse admission of products into the U.S. manufactured at the referenced facilities and may not approve new applications for products from those facilities until FDA has confirmed that corrections have been made.
In focus in both letters were issues regarding: ● environmental monitoring (EM) ● smoke studies to assure unidirectional air flow ● procedures or documentation for differential pressure monitoring ● documentation for validation of autoclave cycles, and ● qualification of operators.
[Comparison and analysis of the Stericon and Oftalmi warning letters and links to the letters are provided for subscribers here.]