Covalent Medical
3 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
your FOCUS PI Post-Injection Eye Drops product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The product is an unapproved new drug marketed without an approved application.
Supporting FDA text
Source excerpt · automated text-match checkyour FOCUS PI Post-Injection Eye Drops product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
The product is misbranded because it does not comply with section 505G and lacks an approved application.
Supporting FDA text
Source excerpt · automated text-match checkyour FOCUS PI Post-Injection Eye Drops drug product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
The product's labeling includes claims for post-injection irritation relief not permitted by the OTC monograph.
Supporting FDA text
Source excerpt · automated text-match checkthe statements made in your product labeling on your website and social media sites include claims for relief of post-injection irritation, which are not permitted indications for ophthalmic demulcent drug products in monograph M018.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Notify FDA in writing of specific steps taken to correct violations
- Explain each step taken to prevent recurrence of violations
- Provide copies of related documentation
- Provide reasoning and supporting information if product believed not in violation
- State reason for delay and time to complete correction if not done within 15 days
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.