Similasan AG
FDA issued a warning letter to Similasan AG, a Swiss homeopathic ophthalmic drug manufacturer, citing that twelve named eye-drop and gel products sold in the U.S. are unapproved new drugs lacking FDA approval under FD&C Act section 505(a). The letter also identifies serious CGMP violations including inadequate aseptic process validation, failure to conduct 100% visual inspection for particulates, incomplete laboratory records, and insufficient quality unit oversight. FDA placed all Similasan AG products on Import Alert 66-40, and the agency warned that continued violations may result in seizure, injunction, and detention of products without physical examination. The company was directed to respond within fifteen working days with corrective actions.
Flagged claims (12)
Similasan Complete Eye Relief is designed for temporary multi-symptom relief from redness, burning, watering, grittiness, dryness, and irritation
Pink Eye Nighttime Gel is a thicker formula made for overnight relief from pink eye symptoms: •Redness •Burning •Watery discharge • Sensation of Grittiness
Dry Eye Nighttime Gel is a thicker gel formula made for nighttime and overnight relief of dry eye symptoms: •Dryness •Redness •Soothes & moisturizes
[T]emporarily relieve symptoms of styes, such as redness, burning, and tearing
Multi-Symptom Relief •Blurred Vision •Eyestrain •Tearing due to Dryness
[T]emporarily relieve minor symptoms such as: •dry eye •redness of eyes and lids •reflex watering secondary to dry eye
Eye drops for symptoms of aging eyes such as cloudy or blurry vision
[T]emporarily relieve minor eye allergy symptoms such as: •itching •burning •excessive watering •redness of eyes and lids
Use As Often As Needed For •Redness •Burning •Watery Discharge •Sensation of Grittiness
[T]emporarily relieve the symptoms of eye strain that may include blurred vision, hypersensitivity to light, and dry eyes
Similasan Aging Eye Relief eye drops are specially designed to support corneal and macular health, and […] provide temporary relief for dryness
Use As Often As Needed For •Dryness •Redness •Soothes •Moisturizes
Required actions (5)
FDA placed all products from your establishment in Switzerland on Import Alert 66-40 on July 24, 2023.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
We may re-inspect to verify that you have completed corrective actions to any violations.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker