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...]
Apotex Research Private Limited, Bangalore, India Receives Warning Letter (1/30/15)
During a June 23, 2014 through July 1, 2014, inspection of the Apotex Research Private Limited (ARPL) manufacturing facilities located at Plot #1 & 2, Bommasandra Ind. Area, 4th Phase, Jigani Link Road, Bangalore, India, investigators from the U.S. Food and Drug Administration (FDA) identified significant violations of current good … [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...]
