Chemolee Lab Corporation Receives Warning Letter (022316) (Click Here) Investigators from the U.S. Food and Drug Administration (FDA) inspected Chemolee Lab Corporation, located at 3820 Conflans Road, Irving, Texas from January 12 thru February 13, 2015 and found a number of CGMP violations for exceeding microbial specifications. These included: Your firm failed to … [Read more...]
Compounding Pharmacies’ Observations Correlate With Those From Large Pharma ISO 5 Facilities
Compounding pharmacies continue to receive citations from the FDA (both Form FDA 483s and Warning Letters) for a continuing failure to meet 21 CFR 210/211 requirements. All one needs to do is visit FDA’s Electronic Reading Room to learn of the ORA audits and the subsequent citations. Even after the New England Compounding Center … [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...]
