OSRX, Inc.

You do not have any FDA-approved applications on file for drug products that you compound. Under sections 505(a) and 301(d) of the FDCA a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug.

their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.

Your facility's drug products, such as Prednisolone Phosphate 1% Moxifloxacin 0.5% 5ml Sterile Ophthalmic Solution and Atropine Sulfate 0.025% 3.5ml Sterile Ophthalmic Solution, did not include the following on the label: a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.

Your facility's drug products, such as such as Prednisolone Phosphate 1% Bromfenac 0.075% 5ml Sterile Ophthalmic Solution and Moxifloxacin 0.5% Bromfenac 0.075% 5ml Sterile Ophthalmic Solution, did not include the following information on the container: (1) information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088; and (2) directions for use, including, as appropriate, dosage and administration.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.

Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.