FDA Inspection OAI
FDA Safety Communication
FDA Untitled Letter
Frankenstein Eye Drop
FDA Inspection OAI
Learn more about these flags
FDA published inspection records for the manufacturing facility of this product on its compliance dashboard in early December 2023. The inspection was classified as Official Action Indicated and there were 15 individual citations. Form 483 is not yet available on FDA domain.
Brand:Regener-Eyes
Country of Manufacture:USA
Package Type:Multi-dose bottle
Contains preservative(s):No
Active ingredient(s):Glycerin 0.4%
Inactive ingredient(s):Sodium chloride, water
NDC(s):82305-003-01
FDA Action:10/5/22 Untitled Letter to Regener-Eyes LLC
4/10/23 Public Safety Notification on Amniotic Fluid Eyedrops
4/10/23 Public Safety Notification on Amniotic Fluid Eyedrops
Last updated:12-11-23