Dynamic Blending Specialists, Inc.
3 extracted findings · 5 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. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals
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 and to validate supplier COA reliability.
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. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals
Failed to test glycerin shipments for identity including DEG/EG limit tests.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to adequately test each shipment of each lot of glycerin for identity, a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination.
Sampling plans for drug products were not justified to represent entire batch quality.
Supporting FDA text
Source excerpt · automated text-match checkYour sampling plans prior to the release of your drug products are not sufficient to assure their quality.
Failed to document adequate monitoring and testing of water system used in products.
Supporting FDA text
Source excerpt · automated text-match checkyou were unable to provide documentation to demonstrate that your (b)(4) water system is adequately monitored and tested for conductivity or microbiology.
Scale calibration logs lacked unique identifiers and were loose pages.
Supporting FDA text
Source excerpt · automated text-match checkYour scale calibration logs consisted of loose pages printed without unique identifiers.
Could not provide non-conformance report because previous data system was not maintained.
Supporting FDA text
Source excerpt · automated text-match checkYou could not provide a non-conformance (NC) report referenced in (b)(4) executed batch records because your previous NC data system was no longer maintained.
Shred bins with apparent CGMP records were located in manufacturing and warehouse areas.
Supporting FDA text
Source excerpt · automated text-match checkShred bins containing what appeared to be CGMP records were located in your manufacturing and warehouse areas.
Water monitoring records stored on personal computer could not be provided.
Supporting FDA text
Source excerpt · automated text-match checkWater monitoring records stored on an employee’s personal computer could not be provided.
Could not provide data supporting labeled expiration dates of drug products.
Supporting FDA text
Source excerpt · automated text-match checkYou could not provide data to support the labeled expiration date of drug products manufactured by your facility.
Marketed an unapproved new drug without an approved application.
Supporting FDA text
Source excerpt · automated text-match check“(b)(4)” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
Product misbranded because it does not comply with OTC marketing requirements.
Supporting FDA text
Source excerpt · automated text-match checkthis product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).
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.
- Describe component lot testing for identity, strength, quality, purity and COA reliability validation.
- Commit to DEG/EG test results for high-risk component retains within 30 days.
- Provide full risk assessment for products containing DEG/EG-risk ingredients and actions.
- Provide chemical and microbiology specifications for incoming high-risk components.
- Conduct independent review of material system and supplier qualification.
- Summarize COA reliability test results and include COA validation SOP.
- Summarize program for qualifying and overseeing contract testing facilities.
- Provide comprehensive assessment and remediation plan for quality unit authority and documentation.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.