Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Receives FDA Warning Letter
Date:11/3/2008

DETROIT, Nov. 3 /PRNewswire-FirstCall/ -- On October 31, 2008, Caraco Pharmaceutical Laboratories, Ltd. (NYSE Alternext US: CPD) received a warning letter from the FDA. The letter was issued as a follow up to the last FDA inspection of the Company's manufacturing facility in Detroit, Michigan which was initiated in May 2008. As previously disclosed, a Form 483 notice was issued in June 2008 following this inspection. The Company had responded to all the observations made in the Form 483 within thirty days thereof, and corrective actions were taken and substantially completed. Subsequent letters noting additional improvements were also provided to the FDA similar to what the Company has done in previous correspondence with the FDA. The observations set forth in the warning letter include, among other things, the inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the Company's standard operating procedures. The FDA considered some of its observations to be repeat observations. The Company believes that the full warning letter, listing all of the observations, will be posted by the FDA shortly on its website at http://www.fda.gov .

Until the Company's responses to the observations have been clarified and explanations provided to the satisfaction of the FDA, the FDA may in the near term withhold approval of pending new drug applications listing the facility as the manufacturer.

Caraco intends to respond promptly and timely to the FDA within fifteen business days. The Company is committed to working cooperatively and expeditiously with the FDA to resolve the matters indicated in its letter. Caraco is confident that any remaining concerns will be addressed and resolved.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's larges
'/>"/>

SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Second Quarter and First Six Months of Fiscal 2009
2. Caraco Pharmaceutical Laboratories Ltd. to Announce Second Quarter of Fiscal Year 2009 Results on October 23, 2008
3. Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the First Quarter of Fiscal Year 2009
4. Caraco Pharmaceutical Laboratories, Ltd. Announces Resignation from Board of Directors of Jitendra Doshi and Appointment of GP Singh Sachdeva
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Methimazole Tablets USP, 5 mg and 10 mg
6. Catalyst Pharmaceutical Partners to Present at the Rodman & Renshaw 10th Annual Global Investment Conference
7. Portola Pharmaceuticals Initiates Phase II Trial of Betrixaban, its Novel Oral Factor Xa Inhibitor for Stroke Prevention in Atrial Fibrillation
8. Memory Pharmaceuticals Granted Extension to Comply with NASDAQ Listing Requirements
9. Idenix Pharmaceuticals Reports Third Quarter and Nine Month Financial Results
10. Anadys Pharmaceuticals Commences Dosing ANA773 in Hepatitis C Patients
11. Morria Biopharmaceuticals Plc to Present at the Rodman & Renshaw 10th Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... (PRWEB) August 29, 2014 The ... $5.6 billion in 2019. It is expected to ... to 2019, and was valued at $1.8 billion ... by Transparency Market Research. , For more information ... http://www.transparencymarketresearch.com/companion-diagnostics-market.html . , The research report, titled “Companion ...
(Date:8/29/2014)... Local veterinarian, Dr. Keith Clement, and ... candidates to participate in an investigational study of donor ... goal of this study is to determine if a ... two arthritically affected joints can help reduce pain and ... the current investigational study must be older than nine ...
(Date:8/29/2014)... TX (PRWEB) August 29, 2014 ... ISO 13485:2003 certified, GAMP® 5 compliant imaging core ... an international Phase II clinical trial to assess ... , Throughout this trial, Intrinsic Imaging will provide ... limited to, protocol and charter development, site qualification, ...
(Date:8/28/2014)... “This kit has an improved extraction efficiency and provides ... ppb,” said Mark Tess, PhD, Mycotoxin Product Manager for Charm ... and USDA-GIPSA inspection agencies that have a need to detect ... in a matter of minutes with nothing but our equipment ... and grain before accepting it, but they no longer have ...
Breaking Biology Technology:Companion Diagnostics Market to Hit $5.6 Billion in 2019: Transparency Market Research 2Companion Diagnostics Market to Hit $5.6 Billion in 2019: Transparency Market Research 3Burnt Hills Veterinary Hospital Seeks Candidates for an Investigational Study of Stem Cells for Dogs with Arthritis 2Intrinsic Imaging Awarded Phase II Clinical Trial to Assess New Treatment for Non-Hodgkin’s Lymphoma 2
... Inc. (Nasdaq: SRLS ) will release its fiscal ... on Friday, February 11, 2011. SeraCare executives will host a ... day to review first quarter results. The ... can be accessed by logging on to the "Investor Center, ...
... Inc. (Nasdaq: PCYC ) today reported recent ... that ended December 31, 2010.Recent Developments & Highlights ... PCI-32765 in B-cell malignanciesPharmacyclics has designed a broad Phase ... and diffuse large B-cell lymphoma to inform the Phase ...
... new way of splitting layered materials to give atom ... a range of novel two-dimensional nanomaterials with chemical and ... electronic and energy storage technologies. The collaborative* international ... Nanostructures and Nanodevices (CRANN), Trinity College Dublin, Ireland, and ...
Cached Biology Technology:Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011 2Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011 3Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011 4Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011 5Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011 6Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011 7Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011 8Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Second Quarter 2011 9New nanomaterials unlock new electronic and energy technologies 2
(Date:8/29/2014)... Boulder, Colo., USA - The rise of the Tibetan ... on Earth -- is important for both its profound ... In this study published in GSA Bulletin , ... -- "clumped" isotope thermometry -- using modern and fossil ... Zhada basin in southwestern Tibet. , Views range ...
(Date:8/28/2014)... pleased to announce the selection of Dr. Fred Baxendale ... acknowledges those who have served ESA for at least ... the Society that has reached an extraordinary level. Candidates ... Board and then voted on by the ESA membership. ... at Entomology 2014, ESA,s Annual Meeting in Portland, Oregon ...
(Date:8/28/2014)... an expansion of marine protected areas is needed to ... According to investigators from the Wildlife Conservation Society and ... on saving the largest numbers of species, often at ... difficult-to-replace ecological functions. , Many vital ecological ... that also are food for millions of people. ...
Breaking Biology News(10 mins):Snails tell of the rise and fall of the Tibetan Plateau 2Snails tell of the rise and fall of the Tibetan Plateau 3Snails tell of the rise and fall of the Tibetan Plateau 4Snails tell of the rise and fall of the Tibetan Plateau 5Snails tell of the rise and fall of the Tibetan Plateau 6Snails tell of the rise and fall of the Tibetan Plateau 7Fred Baxendale selected as Honorary Member of the Entomological Society of America 2Study finds marine protected areas inadequate for protecting fish and ocean ecology 2
... Nov. 14, 2013  Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) ... J. Joseph Kim , has been selected to receive ... from the Korean American Society in Biotech and Pharmaceuticals ... of drug discovery and development through collaborations and information ...
... which fills in a significant gap in the fossil record ... today. A skull from the new species, named Panthera ... Jack Tseng a PhD student at the USC Dornsife College ... and now a postdoctoral fellow at the American Museum of Natural ...
... UC San Diego and their colleagues are unraveling the ... dazzling bioluminescent display in the form of puffs of ... world in muddy environments, from shallow bays to deeper ... marine wormcommonly known as the "parchment tube worm" due ...
Cached Biology News:Inovio Pharmaceuticals CEO Receives 2013 Drug Discovery & Achievement Award 2Inovio Pharmaceuticals CEO Receives 2013 Drug Discovery & Achievement Award 3Inovio Pharmaceuticals CEO Receives 2013 Drug Discovery & Achievement Award 4Inovio Pharmaceuticals CEO Receives 2013 Drug Discovery & Achievement Award 5Fossil of new big cat species discovered; oldest ever found 2Nature's glowing slime: Scientists peek into hidden sea worm's light 2Nature's glowing slime: Scientists peek into hidden sea worm's light 3
RABBIT ANTI NEOPTERIN...
... Beagle Serum • Beagle serum is collected ... one year of age Available Anticoagulants: ... (Na) N-06: K2EDTA N-08: ... N-03: Alsevers N-05: ACD ...
Collected from normal, healthy animals in carefully maintained standing herds of US orgin. Pricing: $45/unit for 1 - 10 units...
Ready-to-use; 40mg/ml X-Gal and 32mg/ml IPTG...
Biology Products: