POSH CHEMICALS PRIVATE LTD RECEIVES FDA WARNING LETTER (8/2/13) During the timeframe of March 3-8, 2013 the FDA inspected Posh Chemicals Private Ltd, Hyderabad, India. A total of three Observations were received. Of particular note is Observation 1 which is similar to Observations from several other Warning Letters to include Sandoz and … [Read more...]
FDA IGNORES CONSIDERATION OF WRITTEN RESPONSES IN DRAFTING WARNING LETTER
CEPHAZONE PHARMA'S (APRIL 25, 2011) INITIAL RESPONSE LACKS SUFFICIENT CORRECTIVE ACTION During our July 12, 2010 to August 26, 2010 inspection of your pharmaceutical manufacturing facility, Cephazone Pharma, LLC, located at 250 E Bonita Avenue, Pomona, CA, investigator(s) from the Food and Drug Administration (FDA) identified significant violations of … [Read more...]
