Kor-Chem, Inc.
7 extracted findings
FDA source excerpt, selected passage
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
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 establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
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 21 CFR 211.84(d)(2)).
Source passage selected by the model
03
You failed to conduct an identity test on each lot of the components (i.e., benzalkonium chloride and glycerin) and failed to conduct adequate identity testing of the active ingredient ethanol, used in the manufacture of your hand sanitizer drug products. You also relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your suppliers’ test analyses at appropriate intervals.
Source passage selected by the model
04
Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).
Source passage selected by the model
05
You failed to test your hand sanitizer drug products for microbiological attributes. Without testing each batch prior to release, you lack scientific evidence that all your drug product batches were free of microbial contamination that is objectionable in view of their intended use.
Source passage selected by the model
06
Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of your drug products. For example, your QU failed to ensure:
Source passage selected by the model
07
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.