Green Pharmaceutical Co. Ltd.
3 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).
Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product container
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
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.
- Commit to provide (b)(4) test results from retains for all high-risk component lots, or perform retain sample testing of finished batches if retains unavailable.
- Provide a full risk assessment for drug products within expiry containing ingredients at risk for (b)(4) contamination, including customer notifications and recalls for contaminated lots.
- Describe how you will test each component lot for identity, strength, quality, and purity, including supplier COA reliability validation and commitment to specific identity testing.
- Provide chemical quality control specifications for testing each incoming lot of high-risk components.
- Provide a comprehensive independent review of your material system to qualify suppliers and ensure incoming material controls.
- Provide a comprehensive assessment and remediation plan to ensure your quality unit has authority and resources, including procedure robustness, QU oversight, batch review, and investigation oversight.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.