An Indian manufacturing company that makes generic eyeglasses sold under the CVS, Target, Rite Aid, and Walmart brands has been accused of manufacturing violations, including allowing workers to perform their duties often without shoes and failing to record insect damage, according to Inspection report released by the Food and Drug Administration.
Last month, editor warn customers to immediately stop using two dozen types of over-the-counter drops because of the risk of infection. The list has since been updated with a few more products. In addition to supermarket brands, eye drops are also sold as President (Cardinal Health), Rugby (Cadinal Health), and Velocity Pharma branded products.
All products are manufactured by Kilitch Healthcare India Limited in Mumbai. At the time of the FDA’s first warning, the agency said it had found bacterial contamination in critical manufacturing areas of the Mumbai facility. As such, the agency warns of the possibility that the products, which are intended to be sterile, may not be edible and may pose a risk of infection.
To date, no infections have been linked to any eye drops. But large retailers quickly began pulling products from shelves on the FDA’s warning. This week, Kilitch launched a voluntary recall of the products.
The inspection report, released recently, offers more details of the FDA’s surprising findings. Inspectors, who inspected the facility between October 12 and 20, found 14 categories of production problems. They include problems with documentation, laboratory controls, data reporting, sanitation, testing, and monitoring.
FDA inspectors found the facility to be in generally poor condition, noting cracked floors, peeling paint, water stains, and dust production. Most shockingly, the inspectors observed workers working without speaking, and working in an unsanitary area of the building, where they should have been wearing shoes—with undercoats, respect, and sandals. (Barefoot workers also don’t wear coats or gloves.) A production manager surprisingly told FDA inspectors that working without shoes was “normal.”
The inspectors also noted that if workers in the company found bacterial contamination registered on the “action” or “alert” level, the test results were not recorded. Instead, the measurement is discarded and the microbiology manager orders more cleaning until the contamination test falls below the alert level. A microbiologist at the company said this happens two to three times a month.
The FDA report noted that over the past five years, the facility’s microbiology laboratory reported no action-level results and only four alert-level results from environmental monitoring and human monitoring. But, when the samples were taken during the FDA inspection-and only between October 16 and 18-there were 39 alert- and action-level discoveries. Of those, 33 were step-level results.
Impressions and memories are part of a chain of disturbing phenomena related to face expression. Earlier this year, an outbreak of drug-resistant bacterial infections linked to EzriCare Artificial Tears came to light. In read new, 81 people in 18 states were affected, including 4 deaths, 4 people needing surgically removed eyelids, and 14 others lost vision. In March, the FDA again raised non-sterility concerns about facial cleansing products Pharmedica we had Apotex.