FDA Recall of contaminated antiseptics

출처: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249706.htm

FDA 보도 자료

즉시 릴리스: April 6, 2011
미디어 문의: 셸리 버지스, 301-796-4651, shelly.burgess @ fda.hhs.gov
소비자 문의: 888-INFO - FDA

FDA는 트라이 어드 살균 제품 오염 문제를 방지하기 위해 행위
미국. 연방 마약 제품 위스콘신 회사가 제조 및 분산 잡다

미국. 집행관, 미국의 요청에. 식품 의약품 관리, have seized more than $6 million in products distributed by Triad Group Inc., 하틀랜드에있는 회사의 시설에서, 위스.

깡패 그룹 및 H & P Industries are owned and managed by the same parties. 약물 제품의 다양한 압수했다, including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, 비강 스프레이, 좌약, 약물 쳐줍니다, antifungal creams, 치질의 잎사귀, 인 - 프로세스 약물 제품, and raw materials.

“We took this action to stop Triad from continuing to distribute products, 공중 보건에 위험을 초래할 수있는,"다라 코리간했다, 규제 업무에 대한 FDA 연관 위원.

작업 H의 지속적인 실패를 다음과 & P Industries to comply with the FDA’s current good manufacturing practice (cGMP) 규정, 안전을 보장하기위한있는, 품질, and purity of manufactured drugs. 이 발작을 통해, FDA seeks to prevent the company from distributing product that was manufactured in violation of federally mandated manufacturing requirements.

In connection with the seizure of the medical products and related items, the First Assistant United States Attorney for the Eastern District of Wisconsin, 그레고리 J. Haanstad, commended officials and staff of the Food & Drug Administration and the United States Marshals Service for their highly effective, 초점, and collaborative work with the Office of the United States Attorney: “The seizures at the H & P Industries facility in Hartland reflect the continuing commitment of all federal law enforcement offices to ensure the safety and the security of our populations—and to safeguard against those whose disregard of professional obligations threaten to compromise public health and well-being.”

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

FDA는 H 자사의 가장 최근의 검사를 완료&월에 P 산업 28, 2011. 검사는 cGMP 요건 여러 위반을 발견, 공기 처리 시스템과 지속적인 문제를 포함하여; 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.

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.