SIMILASAN EYE DROP RELIEF

Product Information

Given that your container closure system uses an (b)(4) vial, provide data supporting that your (b)(4) particle inspection system can adequately detect particles within your container closure.

Cardiospermum halicacabum, also known as balloon plant or flower, is found in subtropical regions such as Africa, South America, India and Australia. The plant is known for it’s anti-inflammatory, itch- and pain-killing properties. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. (21 CFR 211.160(b)) Crocus sativus is used to harvest saffron and is therefor known as one of the worlds most extraordinary spices. In the Ayurvedic medicine the essential oil from the saffron crocus has calming and antipyretic properties. Above all the crocus sativus supports a good mental balance and mood.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices

Eyebright has been used since antiquity for treating conditions of the eye. In eye drops, Euphrasia nurtures and soothes overworked and tired eyes.T]emporarily relieve minor eye symptoms such as: •itching •burning •redness of eyes and lids •stinging •excessive watering •irritation” Now you can soothe a stye with natural medicinal ingredients.Similasan Stye Eye Relief sterile eye drops stimulate the body’s natural ability to temporarily relieve symptoms of styes, such as redness, burning, and tearing. Similasan products are made without harsh chemicals, so you can feel good about feeling better™. Is starts with tenderness and redness around the eye-the beginnings of a stye. Now you have a way to soothe the discomfort. Your response states that your (b)(4) particle inspection system’s imaging processing, that you qualified in 2022 and utilized for 100% visual inspection, “was too slow” and the rejection rate was too high with “false positive[s]” so you suspended its use and implemented manual visual inspections using AQLs, with no 100% visual inspection. As a corrective action, you planned to re-introduce the (b)(4) system on May 1, 2023.

A: The recommended dose is 2-3 drops per eye as needed. Continue use until symptoms diminish. Similasan eye drops can then be used as often as needed.o Take prompt and appropriate actions for all batches of drug products that contain unacceptable levels of ingredients that could cause them to be harmful, including customer notifications and other applicable market actions for any batches containing harmful ingredients. Detail these actions in your response to this letter. When selecting the best eye drops for allergies, we researched dozens of top brands and formulations. We also spoke to allergists and an ophthalmologist to find out what patients should look for in an over-the-counter solution to eye allergy irritation. These experts include: Pet dander, dust, ragweed, grass, and pollen can trigger your eyes to have an allergic reaction. Common OTC allergy medications may help, but according to allergist Dr. Christine Franzese, eye allergies can be hard to treat. Whether it's dryness, redness, or itching, eye drops can provide some relief for the different symptoms of eye allergies. So how do you know if your pink eye is from allergies? Dr. Rapoport says if your symptoms are chronic (i.e., they last over a long period of time, not suddenly), if there is no yellow mucus that comes out, and if the ophthalmologist sees "papillae" or bumps on the inside of the eyelid during an eye exam. 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.

This warning letter also summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). o Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations) There are a few other eye drops and one other eye ointment that have been concurrently recalled in the same period as the two products above — but not due to the same potential bacterial exposure. We're recapping that information below. These eye drops are easy to use, and you can use these drops up to four times per day as needed, but not for more than 72 hours in a row. These drops contain a decongestant which you could become dependent on if you use them consistently. Eye allergies that are seasonal or require longer symptom relief should be treated with a product that doesn’t contain any decongestant. While eye drops that include lubricating ingredients, like the polyethylene glycol found in artificial tears, may be helpful in soothing eye irritation, they don’t actually stop the histamine response at the root of your problems.T]emporarily relieve minor eye symptoms such as: •excessive watery (clear) discharge •sensation of grittiness •redness and burning” When it comes to keeping your eyes nice and moist, Systane is a consistently good choice: With two different kinds of glycol, a humectant that attracts and binds water to the outer layer of a surface, these drops can be applied anytime your eyes need a serious refresher.