Celmade
1 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Products are unapproved new drugs introduced into interstate commerce without approved applications.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.
Products are misbranded because labeling lacks adequate directions for use for prescription drugs.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use these products safely for their intended use. Consequently, the labeling for these drugs products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
- Investigate and determine the root causes of any violations and implement corrective and preventative measures to ensure future and sustained compliance.
- Provide specific steps taken to correct any violations, an explanation of each step being taken to prevent recurrence, and copies of related documentation.
- If you have information demonstrating that your products are not in violation, include that information for consideration.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.