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...]
STILL ANOTHER INDIAN FIRM IS CITED FOR ITS MANAGEMENT OF ITS ISO 5 ENVIRONMENT (8/09/13)
EXTENSIVE CORRESPONDENCE STILL RESULTS IN A WARNING LETTER During the time frame of March 25, 2013 through April 3, 2013 the FDA inspected Promed Exports Private Limited located at Promed Exports Private Limited, Khera Nihla Village, Tehsil Nalagarh, Solan District, Himachal Pradesh, 174101, … [Read more...]
FIRM REPEATLY DECLINES TO RECALL ITS STERILE PRODUCTS
IS THIS THE NEW “POSTER CHILD†FOR NON-COMPLIANCE? On Friday, August 16, 2013 the FDA issued a News Release wherein it reminded “health care providers not to use sterile products from NuVision Pharmacyâ€. The FDA indicated that the rationale behind the News Release was because the … [Read more...]
WOCKHARDT LIMITED, AURANGABAD, INDIA RECEIVES WARNING LETTER (7/18/13)
FIRM IS CITED FOR WITHOLDING TRUTHFUL INFORMATION AND DELAYING AND LIMITING THE INSPECTION Wockhardt Ltd was recently audited by the FDA during the timeframe of March 18 – 22, 2013 at their Biotech Park, Aurangabad, India. During this audit the FDA documented that Wockhardt Ltd was found to have withheld truthful information, and delayed and limited the inspection. The delay … [Read more...]
BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS (USP)
A NEW PROPOSED USP GENERAL INFORMATION CHAPTER USP recently released a new DRAFT in a much anticipated area that has gained significant attention over the past half dozen years. The subject, "USP<1115> Bioburden Control of Nonsterile Drug Substances and Products", has generated much controversy as … [Read more...]
