Cetylite Industries, Inc.
3 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
You utilized a compendial method for the aerosol form instead of using the compendial method for Benzocaine, Butamben, and Tetracaine Hydrochloride Gel to analyze your drug product. You had not appropriately validated that the aerosol method was suitable for testing the gel form of this product.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Firm used an unvalidated aerosol method for gel product and failed to validate alternative methods.
Supporting FDA text
Source excerpt · automated text-match checkYou utilized a compendial method for the aerosol form instead of using the compendial method for Benzocaine, Butamben, and Tetracaine Hydrochloride Gel to analyze your drug product. You had not appropriately validated that the aerosol method was suitable for testing the gel form of this product.
Firm failed to thoroughly investigate OOS results and released product without adequate justification.
Supporting FDA text
Source excerpt · automated text-match checkWithout adequate scientific justification you again retested the sample using two additional methods (b)(4) and (b)(4) and obtained passing results. You then released the product without adequate justification to invalidate the OOS test results including an OOS test result using a compendial test method.
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.
- Commitment to using current USP compendial methods until alternative methods have been demonstrated to be equivalent or better than the USP methods.
- A comprehensive study that determines whether your test methods for your drug products are equivalent to, or better than, the USP method, if you are not using current USP compendial methods. Include all findings and deviations encountered in assessing whether your alternative method is equivalent or superior to the USP compendial method.
- Updated test results using a validated test method (e.g., USP method) of all reserve samples for all drugs released to the market within expiry to ensure that your drug products conform to appropriate standards of identity, strength, quality, and purity.
- Your action plan to address any product quality or patient safety risks for your drug products in U.S. distribution, including potential customer notifications, recalls, or market withdrawals.
- A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for US products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS: Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error. For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.
- For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements. A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following: Quality unit oversight of laboratory investigations, Identification of adverse laboratory control trends, Resolution of causes of laboratory variation, Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified, Adequate scoping of each investigation and its CAPA, Revised OOS investigation procedures with these and other remediations.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.