During March 18-21, 2014 the FDA inspected the pharmaceutical manufacturing facility, Unimark Remedies Ltd., located at 337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District, India. The FDA identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). These deviations caused … [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...]
PAN DRUGS LTD, INDIA, RECEIVES WARNING LETTER (090215) FOLLOWING THE RECEIPT OF AN IMPORT ALERT
An inspection of Pan Drugs LTD, Gujarat, India from July 14-18, 2014 lead to serious deviations that caused their APIs to be adulterated in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing or holding do not conform to, or are not operated or administered in conformity with cGMP. COMMENT: Pan Drugs was placed on … [Read more...]
Another Sunscreen Manufacturer (Jaychem Industries, Ltd.) Receives Warning Letter (090415)
The FDA identified significant violations of current good manufacturing practice (CGMP) regulations during an audit (July 7-10, 2014) of Jaychem Industries, Ltd., Auckland New Zealand and their finished pharmaceuticals, Unfortunately, several other firms to include W.S. Badger Co (Click here) (September 23, 2013), a sunscreen manufacturer, had a huge recall for … [Read more...]
Microbial Limits / Specified Microorganisms Rationale
As a “Frequently Asked Questionâ€, the USP is often queried about the determination of microbial limits and specified microorganisms. The following, obtained from USP, provides a clarification for this commonly asked question. In determining the appropriate microbial limit, the USP Microbiology Expert Committee considers such matters as the … [Read more...]
