Navigation Links
AMRI receives FDA notification on proposed corrective actions
Date:9/26/2011

Albany, NY (September 26, 2011) - AMRI (NASDAQ: AMRI) today announced the receipt of a letter from U.S. Food and Drug Administration (FDA) regarding its Burlington, Massachusetts aseptic finish-and-fill facility, acquired in June 2010. The letter pertained to AMRI's written responses to a August 2010 warning letter and a June 2011 Form 483, and stated that corrective actions proposed by AMRI, once fully implemented, should adequately address the observations made by the FDA investigators.

The Company is on track to fully implement all corrective actions related to the 2011 Form 483 within October of this year and intends to present a written report on the remaining open items to the FDA following completion of these activities. According to the FDA letter, AMRI's corrective actions will be verified by the FDA at the next facility inspection. AMRI has resumed and is continuing manufacturing operations at the Burlington site, including GMP fills for customer projects.

"We are encouraged that the FDA believes the corrective actions we have made and are implementing should adequately address the observations raised from recent inspections," said AMRI's Chairman, President and CEO, Thomas E. D'Ambra, Ph.D. "This is an important, positive step in resolving the issues raised by the FDA with respect to our Burlington, MA facility. Although we believe the actions described in our submissions address the FDA observations, we are continuing to take additional actions to improve our quality, culture and performance at our Burlington operations. We are actively taking steps to rebuild Burlington's book of business. AMRI remains committed to ensuring the quality and safety of our products and processes at all of our locations."


'/>"/>

Contact: Yolanda Meleco
yolanda.meleco@amriglobal.com
518-512-2319
AMRI
Source:Eurekalert

Page: 1

Related medicine news :

1. Brigham and Womens Hospital researcher receives NIH Transformative Research Project Award
2. First US patient receives specially processed donor lungs at the University of Maryland
3. University of Kentucky Sanders-Brown Center on Aging receives $7 million from NIA
4. AMRI receives NIH contract award for development of pre-clinical drug candidates
5. Mayo Clinic receives FDA approval for ovarian and breast cancer vaccines
6. Dale Browne, M.D., ear, nose, and throat specialist, receives award from National Medical Society
7. John House, MD, ear, nose, and throat specialist, receives award from National Medical Society
8. Wayne State researcher receives NSF award to develop neural implants
9. Dr. Joanne Jordan receives Distinguished Service to Rural Life Award
10. Hutchinson Center receives $8.2M to coordinate obesity and cancer consortium
11. Harvard School of Public Health receives $14.1 million to test childbirth checklist
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... ... Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate ... primary prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. ...
(Date:10/13/2017)... ... 2017 , ... Ellevate Network, the leading network for professional women, brought together ... equality at their inaugural Summit in New York City in June. The event was ... of over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... ... 13, 2017 , ... “The Journey: From the Mountains to the Mission Field”: ... souls in the Philippines. “The Journey: From the Mountains to the Mission Field” is ... Bible. She has taught all ages and currently teaches a class of ladies at ...
(Date:10/12/2017)... ... October 12, 2017 , ... The ... demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, ... to meet the highest standard. , These products are also: Gluten Free, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the ... medical article to the newly revamped Cosmetic Town journal section, featuring ... transplant procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi ...
Breaking Medicine News(10 mins):
(Date:10/5/2017)... , Oct. 5, 2017  In response to ... Oral and Maxillofacial Surgeons (AAOMS) released prescribing recommendations ... to be used as a first-line therapy to ... Recognizing the value ... White Paper "Opioid Prescribing: Acute and Postoperative Pain ...
(Date:10/4/2017)... 4, 2017 OBP Medical , ... medical devices, today announced regulatory approval from ... (or Agência Nacional de Vigilância Sanitária (ANVISA)) to ... surgical retractor with integrated LED light source and ... and exposure of a tissue pocket or cavity ...
(Date:10/2/2017)...  AllianceRx Walgreens Prime, the combined central specialty pharmacy ... benefit manager Prime Therapeutics LLC (Prime), today officially began ... unveiling of new signage at its headquarters in ... a few other company-owned facilities across the country. This ... of whom will begin to see the AllianceRx Walgreens ...
Breaking Medicine Technology: