Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation
2 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Quality unit failed to oversee manufacturing, including no component identity testing, no specifications, and no release testing.
Supporting FDA text
Source excerpt · automated text-match checkYour firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Cleaning procedures and validation were inadequate for equipment used to fill hand sanitizer and non-drug products.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
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.
- A complete and final review of each batch and its related information before the QU disposition decision
- Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
- A list of chemical and microbial test methods and specifications used to analyze each lot of your drug product before making a lot disposition decision, and the associated written procedures
- The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing
- A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity
- A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer
- Your standard operating procedure that describes this COA validation program
- A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.