News
Article
ePT--the Electronic Newsletter of Pharmaceutical Technology
Author(s):
On July 18, the US Food and Drug Administration posted a Warning Letter issued Watson Laboratories Caribe, Inc. (Corona, CA) by FDA's San Juan (PR) district office.
On July 18, the US Food and Drug Administration posted a Warning Letter issued Watson Laboratories Caribe,Inc. (Corona, CA) by FDA's San Juan (PR) district office. The Warning,dated June 19, cited manufacturing deficiencies at Watson'sHumacao, Puerto Rico facility. According to the letter, a Nov.3–Dec.15, 2005, FDA inspection uncovered significant deviations from currentgood manufacturing practice (CGMP) regulations including:
FDA recommended Watson Laboratories, "take prompt action to correctthese violations, and you should establish procedures whereby suchviolations do not recur. Failure to do so may result in regulatoryaction without further notice, including seizure and/or injunction."
Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.