TRIAD GROUP AND H & P INDUSTRIES RECEIVE ANOTHER FDA-483 ON MARCH 28, 2011

FDA-483 ARRIVES ONE WEEK PRIOR TO SEIZURE

Comment

The FDA released additional information regarding its most recent inspection (March 21 – 28, 2011) in the same press release that described its seizure of over $6 million dollars of various drug products.   The five page, ten observation FDA-483 (see previous Blog on same subject) continues to demonstrate a pattern that was observed within the previous thirty page, forty six observation FDA-483.  A variety of drug products were seized, including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products, and raw materials. In its press release, FDA advised the following:

“FDA completed its most recent inspection of H & P Industries on March 28, 2011. The inspection found multiple violations of cGMP requirements, including continuing problems with the air handling system; failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility; and failure to take the proper measures to ensure the quality of incoming components.

Since December 2010, H & P Industries has initiated three voluntary product recalls due to various types of bacterial contamination found in the products

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMP requirements. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.”