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# FDA Can’t Locate UK Maker of ‘Filthy’ Eye Drops
- URL: https://www.fdaweb.com/fda-cant-locate-uk-maker-of-filthy-eye-drops/
- Published: 2024-02-27T12:00:00.000Z
- Updated: 2026-09-14T14:24:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156432

FDA says its testing of samples of LightEyez MSM eye drugs obtained through the company’s Web site found that the product is adulterated because “it consists in whole or in part of any filthy, putrid, or decomposed substance.” A 2/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lighteyez-limited-665450-02152024?ref=fdaweb.com) says the company is headquartered in London, UK, and uses a U.S. contract manufacturer for its ophthalmic drug products. The letter says that on 9/15/2023 FDA conducted an on-site investigation at the address listed for the manufacturer, but neither LightEyez nor the redacted manufacturer were found at that location. The agency also notes that LightEyez and its manufacturer stopped communicating with FDA after 8/28/2023 and that FDA has been unable to inspect the manufacturing operations of either LightEyez or its contractor.

The letter says that the company’s ophthalmic products are especially concerning from a public health perspective because the route of administration into the eyes can pose a greater risk of harm to users.

FDA says all 10 composite samples of the firm’s MSM Eye Repair Drops it tested contained gross microbial growth including *Pseudomonas* spp., *Mycobacterium* spp., *Mycolicibacterium* spp., and *Methylorubrum* spp.

The letter reports that during an 8/24/2023 teleconference with the firm’s legal representative in the UK, the representative said the firm supplies drug components to its U.S. manufacturer in Sarasota, FL. LightEyez agreed to voluntarily recall its sterile drug products in U.S. distribution and said that its U.S. manufacturer would process the recall. The letter says no recall has been initiated through FDA.

The agency further found that several of the firm’s products are unapproved new drugs and gives information from the firm’s Web site that provides evidence of the intent that the products be used to diagnose, cure, mitigate, treat, or prevent disease and/or to affect the structure or any function of the body.

LightEyez was told to correct any violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.