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Published March 28, 2013
RVW provides cold storage and visual inspection Read More »
Published March 22, 2013
New program combines clinical trial and bioanalytical activities Read More »
Published March 20, 2013
FDA closes out investigation of Lakewood site Read More »
Published February 20, 2013
Expands manufacturing and support facilities in Craigavon Read More »
Published February 1, 2013
PAI triggered by a top pharma company’s NDA filing Read More »
By Gil Roth
Published January 23, 2013
Will manufacture, distribute more than 100 products while continuing remediation Read More »
By Gil Y. Roth, Contract Pharma
Published January 22, 2013
A preview of our upcoming GDUFA & CMOs article Read More »
By Tony Scott, European Fine Chemicals Group
Published January 22, 2013
Can Mutual Recognition Agreements ensure safety? Read More »
Published January 7, 2013
Successful inspection reviewed procedures and processes for oral solids manufacture Read More »
Published November 14, 2012
2010 warning letter sited nine issues Read More »
By Julie Larsen, BioTeknica, Inc.
Published November 9, 2012
10 Key Questions to Assess Inspection Readiness Read More »
Published October 10, 2012
No observations or recommendations reported Read More »
Published October 8, 2012
Reviewed systems, processes and procedures, with no Form 483 observations Read More »
Published September 26, 2012
Site continues to be compliant with EU GMP Read More »
Published September 18, 2012
Will commence mumps vaccine production Read More »
