Fuller Industries Inc.
4 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.
The quality unit failed to provide adequate oversight, including not ensuring assay testing for the active ingredient is performed and reviewed for every batch, not establishing appropriate procedures for investigating OOS results, not establishing an adequate stability program, not establishing appropriate identification of samples, and not performing annual product reviews.
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).
The firm did not ensure test methods were appropriate for their intended use, lacking a scientifically sound procedure for testing total solids, and used a non-validated method from an internet search that was not specific or appropriate for drug products.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(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
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 comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function, including a determination of whether procedures used by your firm are robust and appropriate, provisions for QU oversight throughout your operations, a complete and final review of each batch and its related information before the QU disposition decision, and oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
- A comprehensive, independent assessment of your overall system for investigating deviations, complaints, discrepancies, OOS results, and failures, with a detailed action plan to remediate this system, including significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures, and how you will ensure all phases of investigations are appropriately conducted.
- A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program, including stability-indicating methods, stability studies for each drug product in its marketed container-closure system before distribution, an ongoing program where representative batches of each product are added each year, detailed definition of specific attributes to be tested at each timepoint, and all procedures describing these elements.
- A comprehensive review of your material system to determine whether all suppliers of components, containers, and closures are each qualified and the materials are assigned appropriate expiration or retest dates, and whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
- A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity, including how you will establish the reliability of supplier's COA results if you intend to accept them, and a commitment to always conduct at least one specific identity test for each incoming component lot.
- Results of tests for DEG and EG in retain samples of all propylene glycol lots, and results for methanol in retain samples of all ethanol lots, used to manufacture your drug products.
- A full risk assessment for drug products that contain propylene glycol and/or ethanol that are within expiry in the U.S. market, with prompt CAPA and details of future actions to ensure appropriate selection of suppliers, ongoing scrutiny of their supply chain, and appropriate incoming lot controls.
- A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies, with a detailed plan to remediate and evaluate the effectiveness of your laboratory system, and 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.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.