Eyedrop Warnings Illustrate Importance of Process Controls
Eyedrops are essential for many people with dry eyes or other conditions, but a recent FDA Warning has shown nearly 30 over-the-counter eye drop products to
Eyedrops are essential for many people with dry eyes or other conditions, but a recent FDA Warning has shown nearly 30 over-the-counter eye drop products to
The specific allegations in the warning letter included detail of the ineffective compliance with the regulation resulting in the serious violations were:
• A resident strain of Salmonella was found in the facility and included some isolates that matched clinical isolates. The pathogen was detected by swab samples taken in the poultry houses which tested positive for SE. Additionally, SE had been previously found across multiple years in these areas, and the species isolates matched several clinical isolates in reference databases.
…