Recently the Office of Combination Products published a list of ”Frequently Asked Questions (FAQ)” that are often asked of the Office. This list of approximately twenty eight questions include several questions with rather obvious answers as well as questions that include where to obtain additional information regarding annual reports. The list includes the roles of the … [Read more...]
ANOTHER PHARMACEUTICAL RECEIVES A WARNING LETTER FOR INADEQUATE AIRFLOW STUDIES (12/17/15)
Over the past several years the FDA has issued Warning Letters to a number of aseptic processing facilities that have encountered difficulties with their management of air flow. While the management of airflow appears to be an easy area to manage within the Aseptic Processing Area (APA), the number of Warning Letters (Click Here) has suggested otherwise. The … [Read more...]
FDA INSPECTION (Medisca) INITIATED FOR APIs FOLLOWING RECEIPT OF REPORTS FOR SERIOUS ADVERSE EVENTS (112515)
COMMENT:  Rarely does one observe such a flagrant number of mislabeled Active Pharmaceutical Ingredients (API) noted within a Warning Letter (Click Here). In this Warning Letter, two of six samples of L-Citrulline repackaged for distribution to Pharmacies for use in compounding were tested by the FDA found to not be as labeled. The firm … [Read more...]
INDIAN MFG FACILITIES RECEIVE WARNING LETTER FOR PROBLEMS ASSOIATED WITH THE ASEPTIC PROCESSING AREA (APA) (102215)
The U.S. Food and Drug Administration (FDA) inspected the following two pharmaceutical manufacturing facilities: August 25-29, 2014: Sandoz Private Limited, MIDC Plot Nos. 8-A/2 & 8-B, TTC Industrial Area, Kalwe Block, Village Dinghe, Navi Mumbai 400 708, Maharashtra, India (Kalwe facility) August 12-28, 2014: Sandoz Private Limited, Plot Nos. D31 & D32, MIDC, TTC … [Read more...]
CANCER CENTER RECEIVES FORM FDA 483 FOLLOWED BY WARNING LETTER A YEAR LATER FOR COMPROMISED ASEPTIC PROCESSING
Over the past several years, the FDA has cited a number of Compounding Centers for compromised aseptic processing. Often this has resulted in only a Form FDA 483. In other cases the actions have resulted in both a Form FDA 483 as well as a subsequent Warning Letter. The Johnson Memorial Cancer Center is one of those that has been cited for both through a 483Â and a … [Read more...]
