Chemco Corporation
6 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
You also failed to establish written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 211.67(b)).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Drug products were adulterated due to CGMP violations including failure to establish cleaning procedures, failure to conduct identity testing, and inadequate quality unit oversight.
Supporting FDA text
Source excerpt · automated text-match checkYou also failed to establish written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 211.67(b)).
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 comprehensive, independent review of your material system, including but not limited to: evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;
- A commitment to always conduct at least one specific identity test for each incoming component lot.
- A commitment to provide **(b)(4)** test results, no later than 30 calendar days from the date of this letter, from testing for all lots of high-risk drug components used in the manufacture of drug products.
- A report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality assurance decisions, and
- A risk assessment and any follow-up actions for the distributed drug products produced without performing any process validation studies.
- 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.