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...]
HAMELN PHARMACEUTICALS, HAMELN, GERMANY RECEIVES WARNING LETTER (12/17/12)
IN-HOUSE STERILITY TESTING METHOD NOT EQUIVALENT TO USP<71> During the time frame of June 4 - 14, 2012, the Hameln facility was audited by the FDA. Following the audit, the firm responded on July 4, August 2 and 31, and September 8, 2012. Even with all of these responses, the FDA found that the firm lacked sufficient corrective actions. For … [Read more...]
PERFORMANCE PRODUCTS INC, ST LOUIS, MO RECEIVES WARNING LETTER (11/20/12)
COMPANY FAILS TO REPLY TO FORM FDA 483 FROM JULY 2012 AUDIT Compliance Products, St. Louis, MO was audited by the Kansas City office of the FDA from July 16-20, 2012. Following the audit, a total of eight Observations were issued. As of the date of the Warning Letter, no response had been received by the FDA. Many of the Observations represented recurring Observations – … [Read more...]
