Dextrum Laboratories Inc.
5 extracted findings · 4 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.
Failed to perform identity testing on each component lot, including high-risk components for DEG/EG contamination.
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)).
Failed to adequately test each shipment of each lot of incoming components at high risk for DEG/EG contamination, including glycerin.
Supporting FDA text
Source excerpt · automated text-match checkFurthermore, your firm failed to adequately test each shipment of each lot of incoming components at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination. This includes, but is not limited to, testing of glycerin you use in manufacturing drug products to determine its appropriate identity.
Failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use. (21 CFR 211.84(d)(6)).
Failed to adequately monitor the microbiological quality of water used to manufacture aqueous-based OTC drug products.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to adequately monitor the microbiological quality of the water you use to manufacture your aqueous-based OTC drug products. Specifically, you only test your (b)(4) water for microbiological attributes and total organic carbon (TOC) on a (b)(4) basis.
Failed to adequately validate production and process controls, including for a specific OTC drug product.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to adequately validate your production and process controls. As such, you do not have assurance that you are capable of consistently manufacturing OTC drug products with defined quality attributes.
Process validation studies were not representative of all drug products manufactured.
Supporting FDA text
Source excerpt · automated text-match checkYou have not provided an adequate scientific justification that the process validation studies conducted for “(b)(4)” drug in each group is adequate and fully representative of the production and process controls for the other approximately (b)(4) drug products you manufacture.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Commitment to provide DEG and EG test results from testing retains for all lots of high-risk drug components used in manufacture, or retain sample testing of all implicated finished drug product batches for DEG and EG.
- Full risk assessment for drug products within expiry containing any ingredient at risk for DEG or EG contamination, including customer notifications and recalls for contaminated lots.
- Description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity, including commitment to always conduct at least one specific identity test for each incoming component lot.
- Chemical quality control specifications used to test each incoming lot of high-risk drug components.
- Comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures are qualified and materials are assigned appropriate expiration or retest dates.
- Commitment to perform retrospective testing of aqueous-based finished drug product retains, within expiry, to ensure they meet all microbiological quality attributes.
- Summary of your program for qualifying and overseeing contract facilities that test the (b)(4) water you produce.
- Commitment to perform increased microbiological testing of your (b)(4) water system until qualification is complete and appropriate monitoring procedure is established, and to develop a procedure for ongoing control, maintenance, and monitoring of the water system to meet USP monograph specifications and microbial limits.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.