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Validation Times articles from March 2008
Monthly newsletter that publishes FDA inspection reports for cleaning, computers, process, and utilities. Includes news and compliance tips, guidance and regulation tracking, and analysis of FDA warning letters of validation.
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Validation Times archives from March 2008
FDA, USP to use compendial tests for heparin, possibly NMR; agency to add inspectors in China.(Imports)
March 1, 2008... FDA has initiated a partnership with the U.S. Pharmacopeia to develop "compendial tests in an expedited manner" on heparin and testing for purity, Center for Drugs Director Janet Woodcock, M.D., stated in a March 20 press conference.
The...
Violations of new FDAAA 2007 up to $100 million for multiple offenses.(Civil penalties)
March 1, 2008... ARLINGTON, VA -- The four key components of the Food and Drug Administration Amendments Act of 2007 (FDAAA) are post-approval study requirements, safetyrelated label changes, risk evaluation and mitigation strategies (REMS), and pre-review of...
FDAAA 2007 has impact on AREA and BPCA.(Pediatric drugs)
March 1, 2008... ARLINGTON, VA -- The Pediatric Research Equity Act (AREA) under FDAAA 2007 has been changed to provide more complete inclusion of results of pediatric assessments on labeling, with all adverse drug experiences (ADEs) for one year after labeling...
$225 million authorized under FDAAA 2007 Act for PDUFA user fees.(PDUFA)
March 1, 2008... ARLINGTON, VA -- In the recent FDA Amendments Act (FDAAA) of 2007, FDA requested an additional $392 million in user fees under PDUFA, $87.5 million more than under previous PDUFA legislation. Congress authorized an additional $225 million,...
REMS frequency seen increasing under FDAAA 2007, former chief counsel says.(Post-marketing surveillance)
March 1, 2008... ARLINGTON, VA -- Risk evaluation and management strategies (REMS) are expected to increase under the FDA Amendments Act (FDAAA) of 2007, a former chief counsel of FDA told a CBI conference here March 10.
Sheldon Bradshaw, now with the...
BASF receives 483 for unvalidated computer systems.(Human drugs)
March 1, 2008... BASF Aktiengesellshaft, Ludwigshafen, Germany, was slapped with a six-item 483 for computer labeling systems that were not properly validated.
According to the audit records, compiled by investigator Michele Perry-Williams and chemist...
Biozyme gets 3-item 483 for inadequate investigations of API validation batches.(Human drugs)
March 1, 2008... Biozyme Laboratories, Blaenavon, South Wales, U.K., received a three-item 483 because its investigations into the production of API validation batches were not complete.
The audit of the manufacturer of active biopharmaceutical...
Changzhou fails to remove impurities, check OOS results.(Human drugs)
March 1, 2008... Changzhou SPL Company, the company implicated in Baxter's heparin recall, received an 11-item 483 in a February audit because of its evaluation of the steps it takes to remove impurities; its investigation of out of specification (OOS) results;...
Eli Lilly-Clinton Labs receives hefty EIR, but no 483 issued.(Human drugs)
March 1, 2008... Eli Lilly-Clinton Labs, Clinton, IN, did not receive any citations in three recent FDA inspections, but FDA left the firm with an extensive EIR, listing a number of verbal observations that were not cited on a 483.
The first audit was...
Gebauer tripped on CAPAs and environmental condition procedures.(Medical devices)
March 1, 2008... Gebauer Company, Cleveland, OH, received a three-item 483 following a recent GMP audit because the device manufacturer failed to implement corrective and preventive actions (CAPAs), and because appropriate procedures have not been defined for...
Vintage Pharma tripped up by microbiological contamination.(Human drugs)
March 1, 2008... During an inspection of the manufacturing facility of Vintage Pharmaceuticals, Huntsville, AL, on July 16-20, 23-25, and Aug. 8, 2007, investigators from FDA documented significant violations of GNP regulations, causing the firm's drug products...
Design control procedures faulty, notes Baxa Corp. warning letter.(Medical devices)
March 1, 2008... An inspection of Baxa Corporation, Englewood, CO, July 12- 30 resulted in FDA's determination that the company's "electro-mechanical infusion pumps and related sterile tubing sets, electro-mechanical pharmacy compounders, mixers and...