Sanitizer Supply LLC
4 extracted findings
FDA source excerpt, selected passage
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug** **product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug** **product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Source passage selected by the model
02
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
Source passage selected by the model
03
You failed to test incoming components and active ingredients (e.g., BZK) for identity. This was confirmed in your signed affidavit provided to our investigator. Your firm relied on the certificates of analysis (COA) from unqualified suppliers without establishing the reliability of each of your suppliers’ COA for the component specifications and characteristics.
Source passage selected by the model
04
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.