FDA INVESTIGATOR FINDS INACCURATE REPORTING OF MICROBIOLOGICAL DATA The FDA, during August and October 2012 inspected two Apotex, Inc. sites. This Blog only discusses the facilities located at 150 Signet Drive, Toronto, Canada. The U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) … [Read more...]
APOTEX INC RECEIVES WARNING LETTER FOR MULTIPLE CANADIAN SITES (2/21/13)
FIRM FAILED TO ESTABLISH AND FOLLOW PROCEDURES DESIGNED TO PREVENT MICROBIOLOGICAL CONTAMINATION (21 CFR 211.113(b)) The FDA, during August and October 2012 inspected two Apotex, Inc. sites. This Blog only discusses the facilities located at 150 Signet Drive, Toronto, Canada. The U.S. Food and Drug Administration (FDA) identified significant … [Read more...]
JUBILANT HOLLISTERSTIER RECEIVES WARNING LETTER (2/13/13)
ASEPTIC FILLING FACILITY RECEIVES SIGNIFICANT OBSERVATIONS Jubilant HollisterStier located in Kirkland, Quebec, Canada was audited by the FDA on March 19-26, 2012. Following the receipt of the Form FDA 483, the Company responded on April 13, 2012 to the Observations and subsequently on May 1, June 1, and August 9, 2012. The various violations caused the drug products to be … [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...]
ABBEY COLOR, PHILADELPHIA, PA RECEIVES WARNING LETTER (FEBRUARY 19, 2013)
API MANUFACTURING FACILITY IS CITED FOR SEVERAL REPEAT WATER RELATED OBSERVATIONS During the time frame of March 13 to March 23, 2012 the FDA inspected Abbey Color, an active pharmaceutical ingredient (API) manufacturing facility in Philadelphia, PA. Following a detailed review of the firm’s response, dated April 12, 2012, the FDA concluded that … [Read more...]
