As a “Frequently Asked Questionâ€, the USP is often queried about the determination of microbial limits and specified microorganisms. The following, obtained from USP, provides a clarification for this commonly asked question. In determining the appropriate microbial limit, the USP Microbiology Expert Committee considers such matters as the … [Read more...]
CANTON LABORATORIES PVT. LTD, INDIA RECEIVES WARNING LETTER (2/27/14)
FIRM FALSIFIES MICROBIAL DATA Canton Laboratories, India was found to have reported analytical results without having performed the testing. C of A’s stated that the data conformed to specifications; however, multiple personnel confirmed that the testing was not performed. Similar data was observed in July 2008 with other testing. Please read below to learn more about … [Read more...]
CAPCO CUSTOM PACKAGING INC RECEIVES WARNING LETTER (02/20/13)
DIETARY SUPPLEMENT MANUFACTURING FACILITY FAILS TO ADEQUATELY PERFORM MICROBIOLOGICAL TESTING; FDA CITES INCORRECT USP CHAPTER COMMENTS Dietary Supplement Warning Letters have within the past several months been issued at a frequency of two to three each week. Many of these Warning Letters demonstrate that the recipient fail to follow even the most basic Dietary Supplement … [Read more...]
