AnuMed International, LLC
6 extracted findings · 7 model-assigned issue types
FDA source excerpt, selected passage
your above-mentioned products are unapproved new drugs 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.
Products are unapproved new drugs introduced into interstate commerce without approved applications.
Supporting FDA text
Source excerpt · automated text-match checkyour above-mentioned products are unapproved new drugs 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).
Products are misbranded because labeling misleadingly suggests FDA approval or endorsement.
Supporting FDA text
Source excerpt · automated text-match checkthe product labels and/or websites include statements that misleadingly suggest that the drug products are approved or endorsed by FDA in some way.
Products fail to bear adequate directions for use because they are intended for diseases not amenable to self-diagnosis or treatment.
Supporting FDA text
Source excerpt · automated text-match checkyour before-noted products fail to bear adequate directions for their intended uses and, therefore, are misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1).
Failed to conduct at least one identity test for each component lot, relying on supplier COAs.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to perform adequate identity testing, including specific identity testing as appropriate, for each shipment of each lot of components, such as glycerin and ethyl alcohol (ethanol; alcohol), used in the manufacture of your drug products.
Failed to establish written production and process control procedures, including lack of process validation.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to adequately validate your processes used to manufacture your drug products and demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality.
Failed to adequately qualify and monitor the purified water system used in manufacturing.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to adequately qualify your purified water system. You also failed to show that your water system is adequately monitored to ensure it consistently produces water that meets appropriate microbial limits.
Failed to validate non-compendial microbial test methods and used expired test materials.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to validate your non-compendial microbial methods used to test drug products and assure the methods were equivalent to or better than USP methods.
Quality unit failed to provide adequate oversight, including record retention, batch documentation, annual product reviews, and training.
Supporting FDA text
Source excerpt · automated text-match checkYour quality unit (QU) did not provide adequate oversight for the manufacture of your drug products.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity.
- The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.
- A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates.
- A commitment to provide test results for components used in the manufacture of your drug products, no later than 30 calendar days from the date of this letter, including testing retains for all lots of drug components at high-risk for DEG and EG contamination, and pharmaceutical alcohol for methanol contamination.
- A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG, EG, or methanol contamination.
- A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures.
- A timeline for performing PPQ for each of your marketed drug products.
- Include your process performance protocol(s), and written procedures for qualification of equipment and facilities.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.