SIMILASAN EYE DROP RELIEF

Product Information

The mere mention of OTC eye drops probably makes you think of Visine. The company has been doing eye care for decades, and they offer several different formulations of drops designed to help with literally any eye problem you could possibly have (yes, even eye strain from too much screen time). Similasan Aging Eye Relief eye drops are specially designed to support corneal and macular health, and […] provide temporary relief for dryness” o Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations) Your response is inadequate. There is no commitment to conduct a retrospective review for your released drug products that only relied on the AQL sampling to try and assure product quality and limit patient risk. Additionally, your response did not include supportive documentation for routine osmolarity testing of your ophthalmic drug products.

A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation. o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsT]emporarily relieve minor eye allergy symptoms such as: •itching •burning •excessive watering •redness of eyes and lids” Anyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. Severe eye infections may often go ignored or misdiagnosed without clinical care, and left untreated, could cause life-threatening complications, especially with drug-resistant strains of bacteria like the one being traced by CDC officials. T]emporarily relieve minor eye symptoms such as: •dry eye •redness of eyes and lids •reflex watering secondary to dry eye” It's okay to use these drops rarely if you need to—however they will not provide long-term allergy relief [and can also] create rebound redness,” explains Dr. Dass. Delsam Pharma Artificial Eye Ointment: Produced by the same manufacturer, Delsam's topical ointment hasn't been linked to current cases as recorded by the CDC, but is being recalled due to "possible microbial contamination." While it's not technically an eye drop product, implicated tubes of ointment (which is used on skin in proximity to the eye) can be identified with the NDC 72570-122-35 and UPC code 3 72570 12235 3.

T]emporarily relieve minor eye symptoms such as: •excessive watery (clear) discharge •sensation of grittiness •redness and burning” T]emporarily relieve minor eye symptoms such as: •itching •burning •redness of eyes and lids •stinging •excessive watering •irritation” Your inadequate media fill studies compromise your ability to accurately assess the state of validation and process control. To ensure a valid assessment, it is critical that media fill studies accurately simulate the number and type of interventions that occur during commercial manufacturing. Medicinal ingredients: Conium maculatum, Conium (fresh aerial parts) 6X; Graphites, (naturally occurring mineral graphite) 12X; Sulfur, (sublimed sulfur) 12X Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure:Your unapproved ophthalmic drug products are especially concerning from a public health perspective, particularly given your firm’s significant violations of CGMP regulations. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses. 1 The written procedures for your media fills were not appropriate because they failed to accurately simulate commercial manufacturing. Our inspection found that aseptic interventions simulated during your media fills were not sufficiently representative of commercial aseptic manufacturing. For example, the number of interventions conducted during your manually intensive commercial operations exceeded the number performed during your media fills as follows, We note that your ophthalmic drug products utilize silver sulfate as a preservative. The Agency has significant concerns regarding the safety of silver sulfate for use as an ophthalmic preservative. Long term use of medicinal compounds containing silver may cause argyria, which is a blueish-gray discoloration of the skin and eyes that is irreversible. Additionally, granular deposits of silver in the conjunctiva and cornea may cause decreased night vision. Accordingly, we are concerned that your use of silver sulfate as a preservative in your ophthalmic products is inconsistent with 21 C.F.R. 200.50(b)(1), under which ophthalmic preservatives should be “suitable and harmless.” FDA relayed our concerns regarding this issue with you on July 14, 2023. Because eye drops often focus on relieving a single symptom of allergies, you’ll have to experiment a little when it comes to finding a product that works for you. If you only have one symptom, like dryness, you don’t need a multi-action drop. On the other hand, if your eyes are itchy, red, and watery, that might be your best bet.