FDA BAM Chapter 23 – Cosmetic Testing / Import Detention
- FDA Registration FEI# 1000151293 as a GMP/GLP/GCP Drug Establishment and Cosmetic Facility.
- DEA Registration# RC0199744 (Analytical Lab) | Schedule I-V license | Remember, Schedules I-II require DEA Form 222 | Registration# RC0171568 (Researcher)
- US EPA/NJ DEP Registration# NJD982726648
- ISO/IEC 17025:2017 Accreditation# 80071
CPT℠ routine performs microbiological testing of personal care and cosmetic products using FDA BAM Chapter 23.
Testing by this chapter involves testing for Total Aerobic Microbial and Total Yeast/Mold Counts as well as Enrichment for objectionable Microorganisms as well as Identification of Microorganisms that are potentially isolated.
CPT℠ can assist with testing of FDA detained imported cosmetics that potentially violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) by placing non-compliant products or manufacturers on Import Alerts. Detentions—often executed as Detention Without Physical Examination (DWPE)—which are many times triggered by microbiological contamination of these cosmetics.
CPT℠ Can Help
CPT℠ has experience to assist by testing according to the sampling plan outlined by the FDA and provide analytical testing packages directly to the FDA after testing is complete to provide evidence of presence or absence of microbiological contamination. If no microbiological contamination is present, this can help in facilitating release of detained products if this was the primary reason for the import detention.
Contact CPT℠ to learn more and schedule testing of your products and formulations.