ABR Laboratory LLC
3 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The firm did not verify that its test method was equivalent or better than the USP compendial method and failed to perform method suitability for certain OTC drug products.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
The firm did not investigate a temperature excursion in a refrigerator storing reference microorganisms, which could compromise their growth and the accuracy of test results.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
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.
- Provide a comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
- Provide a retrospective review to determine the scope and the impact of the violation. The review should include a procedure to re-test drug product potentially affected by the violation and a procedure that details steps you will take in the case previously negative results are shown to be positive for microbial contamination, including notifying your customers.
- Provide updated procedures documenting how the suitability of all test methods will be determined, when method verification and validation occur, and corresponding training records.
- Provide a comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.