FDA QUESTIONS FIRM’S BASIC UNDERSTANDING AND MICROBIAL CONTROLS CRITICAL FOR THE MANUFACTURE OF STERILE PRODUCTS Agila Specialties Private Ltd, located at Bommasandra Jigani Link Rd., Bangalore, India was audited by the FDA from June 17 to June 27, 2013. The audit resulted in the FDA continuing to consider their Import Hold on this facility. Significant Observations included … [Read more...]
FIRM RECALLS SUNSCREEN LOTIONS FOLLOWING RETESTING
MICROORGANISMS INCLUDE GRAM NEGATIVE BACTERIA, YEAST AND MOLDS On Monday, September 23, 2013 W.S. Badger Co. announced a voluntary recall of all lots of its 4-ounce Baby SPF 30 Sunscreen Lotion and one lot of its 4-ounce SPF Kids Sunscreen Lotion because of microbial contamination. The recall is being conducted with the knowledge of the U.S. food and Drug … [Read more...]
TESTING LABORATORY RECEIVES STERILITY OBSERVATIONS
FDA FINDS LABORATORY CONDUCTING STERILITY AND ENDOTOXIN TESTING FOR COMPOUNDING CENTERS HAS SIGNIFICANT ISSUES WITH STERILITY ASSURANCE The FDA recently audited Front Range Laboratories, Loveland, CO from August 5 through August 30, 2013. Their five investigators issued a five Observation, twelve page document. Enclosed is Observation 1 which … [Read more...]
FAILURE TO PROTECT COMPUTERIZED DATA – A REMINDER OF SANDOZ AND CEPHAZONE PHARMA’S FDA WARNING LETTER ISSUES
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...]
