# FDA WARNING_LETTER - LightEyez Limited - September 15, 2023

Source: https://www.keypedia.com/records/warning_letter/lighteyez-limited/e510d88f-a14f-4132-ba2d-72200911399a

> FDA WARNING_LETTER for LightEyez Limited on September 15, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: LightEyez Limited
- Inspection Date: 2023-09-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to LightEyez Limited due to significant violations concerning their ophthalmic drug products, including "LightEyez.com MSM Eye Drops v2.0 – Eye Repair" and other MSM, color-changing, and eye-lightening drops.

FDA testing of "MSM Eye Repair Drops" revealed gross microbial contamination (e.g., Pseudomonas spp., Mycobacterium spp.), rendering the product adulterated under 21 U.S.C. 351(a)(1) as it consists of filthy, putrid, or decomposed substances. This poses a high risk of severe ocular infections. The company's manufacturing methods, facilities, and controls also do not conform to Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), leading to adulteration under 21 U.S.C. 351(a)(2)(B). LightEyez failed to provide adequate quality oversight of its U.S. manufacturer, (b)(4), which admitted to using unfiltered municipal water due to a malfunctioning system.

Furthermore, all MSM, color-changing, and eye-lightening eye drop products are deemed unapproved new drugs under 21 U.S.C. 355(a) because they are not generally recognized as safe and effective for their intended uses, as evidenced by therapeutic claims on the product labeling and website (e.g.,

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Steve McDonald](https://www.keypedia.com/people/steve-mcdonald/26e00c2e-6f05-441a-b129-198ddd6e82ea)

Company: https://www.keypedia.com/companies/lighteyez-limited/142abc5b-8c84-4ad6-a37c-da037f1d603d

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c