Does anybody have any good background on this place in Burlington, MA ? I think I have potential offer there, but the turnover looks heavy.
They got purchased by AMRI in the summer of 2010. Then they got hit with 14 483's. AMRI ousted the President and VP of Business Development (husband-wife team). There's probably another 20 483's that the FDA didn't catch though.
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.” AMRI Burlington is an established provider of cGMP manufacturing and sterile filling of parenteral drugs using specialized technologies including lyophilization and BUBBLE-FREE FILLING®, a unique patented technology. These services are provided for both small molecule drug products as well as biologicals, from clinical phase to commercial scale. Located in Burlington, Massachusetts, the site includes approximately 95 employees. Contact Information: 99 South Bedford Street Burlington , MA 01803 info@amriglobal.com Phone: 781.270.7900 Fax: 781.270.7899 Areas of Expertise: Aseptic Fill & Finishing Services
That place is do disheveled. yeah FDA missed a lot of other observations, among OSHA and DEA violations. Hope someone doesn't whistle blow or bye bye AMRI
Heh heh - Money Pit - Great job Shawn Kinney! http://www.outsourcing-pharma.com/Contract-Manufacturing/Hyaluron-buy-a-money-pit-for-AMRI-analyst-warns?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright Hyaluron buy a “money pit” for AMRI, analyst warns FDA scrutiny of the Burlington, MA sterile plant AMRI bought in 2010 has made the takeover a “money pit”, an analyst said. Manufacturing was a second quarter highlight at AMRI, with both small and large-scale increasing sales by close to 20 per cent. However, AMRI continues to face regulatory scrutiny at the Burlington, Massachusetts sterile syringe and vial filling plant it acquired in the 2010 takeover of Hyaluron. “This acquisition has become a money pit, suffering from the combination of revenue impairment from regulatory holdups and higher costs to fix those issues. Regaining clients if and when these items are cleared is a steepening hill to climb”, David Windley, equity analyst at Jefferies & Company, said. In August 2010 AMRI received a US Food and Drug Administration (FDA) warning letter following an inspection of the plant. A re-inspection lasting most of June found AMRI had fixed the issues raised in the warning letter, but discovered seven other concerns that led to the FDA sending a Form 483. AMRI is working to fix the new problems and get the facility back to normal operation. However, it is unclear how long this will take and “there can be no assurance that the FDA will be satisfied with [its] response”, AMRI said in a US Securities and Exchange Commission filing. Discovery demand The discovery services unit was another drag on second quarter results, with sales dropping 25 per cent year-on-year. However, AMRI is encouraged by request for proposals (RFP) activity and is in talks with up to eight large pharma companies interested in outsourcing discovery work. AMRI had hoped to ink deals in 2011 but next year is now more likely. “Due to budget delays and portfolio rationalisation, the RFPs are not expected to be awarded and produce revenue until early 2012. Given that backdrop, the eventual timing should be viewed with caution”, Windley said. On a day when double-digit drops were fairly common, with both Parexel and Charles River experiencing such declines, shares in AMRI closed down 11.7 per cent.
