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...]
PHARMACIA UPJOHN FACILITY RECEIVES SECOND FDA FORM 483 IN ALMOST FIVE YEARS
IS A WARNING LETTER FORTHCOMING? A Pharmacia Upjohn subsidiary of Pfizer (Kalamazoo, MI) received a FDA Form 483 following an inspection from June 23 through July 9, 2015. This eight Observation 483 covered both non-sterile and aseptic issues. This audit used the Agency’s recently introduced team-based inspection approach and included Thomas Cosgrove, … [Read more...]
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC, ORANGEBURG, NY RECEIVES FORM FDA 483 (7/5/11)
BACILLUS CEREUS RECOVERED FROM APPLICATOR USED TO MANUFACTURE NON-STERILE ALCOHOL PREP PADS OBSERVATION 1 Each lot of a component that is liable for microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use. COMMENT 211.065(3) (d) and 21 CFR 211.113(a) discuss the need to test components prior to … [Read more...]
MIRAMAR COSMETICS RECEIVES WARNING LETTER (AUGUST 18, 2011)
WARNING LETTER IS RECEIVED FOR REPEAT VIOLATIONS AND OBJECTIONABLE (SPECIFIED) MICROORGANISMS COMMENT Miramar Cosmetics of Doral, Florida received a Warning Letter for repeat violations from 2007, the presence of objectionable (“specified”) microorganisms, responding after 15 business days after the Form FDA 483 was issued and the manufacturing of drugs without an approved … [Read more...]
ALLURE LABS RECEIVES WARNING LETTER (5/24/11)
ALLURE LABS’ CITED FOR FAILURE TO CALCULATE MICROBIOLOGICAL DILUTION FACTOR CORRECTLY WITHIN PRODUCT LEADS TO PRODUCT FAILURE We have reviewed your firm’s response dated December 12, 2010, and note that it lacks sufficient corrective actions. We acknowledge your second written response, dated February 3, 2011, to the Form FDA 483. However, because this response was received … [Read more...]
