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...]
MEDI-FARE DRUG AND HOME HEALTH CENTER, BLACKSBURG, SC RECEIVES WARNING LETTER (3/7/13)
SERIOUS DEFICIENCIES ARE NOTED IN THE PRACTICE OF PRODUCING STERILE DRUGS BACKGROUND Recently the FDA has been criticized for its management of the New England Compounding Center. The following Warning Letter represents one of the first Warning Letters that the Agency has issued in a similar area since the issue of Compounding Pharmacies has become a national … [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...]
NOVO NORDISK A/S RECEIVES WARNING LETTER (Bagsvaerd, Denmark, 12/12/12)
LACK OF ENVIRONMENTAL MONITORING DURING 23 MONTHS ATTRACTS FDA ATTENTION Approximately one year ago (March 12 - 20, 2012), the FDA audited the Novo Nordisk A/S facility located at Novo Alle, Bagsvaerd, Denmark. During the audit the FDA encountered significant deviations that lead to the following Warning Letter. Observation 1 states that “your firm has not established or … [Read more...]
