Validation Times articles from April 2004

Validation Times archives from April 2004

Industry faces more criminal charges as FDA turns to U.S. attorneys for enforcement backup.(Compliance/enforcement)
April 1, 2004... WASHINGTON -- FDA's enforcement activities have taken a new twist toward criminal enforcement as the agency "tries to take the biggest bite that it can," Steven Kowal, an attorney with Chicago-based Bell, Boyd and Lloyd, told attendees at the...

'Like-for-like' changes need not come under GMP change requirements, but open changes draw FDA ire.(Change control)
April 1, 2004... Manufacturers need not conduct change control for "like for like" revisions in components, parts or other equipment, or repairs, but FDA inspectors will not like to see open change controls and a lack of closure, a GMP expert advised April 13....

Cleaning citations on 483s, warning letters on the rise, expert says.(Cleaning validation)
April 1, 2004... SAN DIEGO -- A pharmaceutical industry consultant, who conducts GMP audits and evaluations of chemistry, manufacturing and controls (CMC), said many of the 483s and warning letters she reviews cite insufficient or lack of cleaning validation as...

Federal pre-emption law may benefit drug manufacturers, lawyers advise.(Labeling/pre-emption)
April 1, 2004... WASHINGTON -- Recent rulings by state supreme courts that upheld federal pre-emption laws were seen by many to benefit pharmaceutical manufacturers, lawyers argued during the Food & Drug Law Institute's (FDLI) 47th Annual Conference here April...

FDA-SEC partnership raises questions about disclosure of development and trial reports.(Drug development)
April 1, 2004... WASHINGTON -- FDA's efforts to have drug and biologics makers disclose their "development reports" as part of the agency's drug quality initiative could present some exposure industry had not realized due to the agency's new working agreement...

AAI lacked validation data, evades 483.(Human drugs)
April 1, 2004... AAI International managed to avoid a 483 following a pre-approval inspection last year, although it lacked validation data and an approved assay specification. Although a 483 was not issued, several deficiencies in the process were...

Nerve gas antidote maker nets 483 for cleaning validation, aseptic deficiencies.
April 1, 2004... Meridian Medical Technologies was found to be in "substantial" compliance with GMPs, but received a three-item 483 from FDA for inadequate smoke studies of its Class 100 filling area as well as inadequate sanitization in aseptic areas. A...

Poor validation, stability studies net Searle 10-item 483.
April 1, 2004... Inadequate validation and stability studies for Searle's manufacturing processes for several drugs were discovered during a GMP inspection of the firm's Puerto Rican plant. The plant serves as a contract manufacturer of tablets and...

Wyeth's Fort Dodge facility cited for sterile filling, environmental monitoring, other GMP faults.(Animal drugs)
April 1, 2004... Wyeth's Fort Dodge animal drug manufacturing plant in Fort Dodge, IA, received a warning letter March 31 for a variety of GMP problems, notably for faults in sterile filling, environmental monitoring and failure to follow SOPs. Sterile...

Red Cross' cryopreserved heart valve/human tissue services cited for validation violations.(Biologics/medical devices)
April 1, 2004... Important aspects of American Red Cross Transplantation Services,' Costa Mesa, CA, validation processes were missing, the agency discovered during an investigation conducted between Oct. 20 and Nov. 25, 2003. According to a March 11...

CPR system manufacturer fails to validate automated production machinery software.(Medical devices)
April 1, 2004... Some of the most serious violations noted by FDA investigators George Calafactor and Anthony Petriella following an inspection at Michigan Instruments, Grand Rapids, MI, Nov. 4-Dec. 9, 2003, included the firm's failure to validate computer...

Cordis fails six-site, post-approval inspection.
April 1, 2004... FDA noted numerous violations following post-approval inspections of six facilities owned by Cordis Corp., Miami Lakes, FL, all involving the design, manufacture and distribution of the Cypher Sirolimus-Eluting Coronary Stent. According to...

Chambermaid Products hit with sundry QS violations.
April 1, 2004... Quality System procedures were not in place at Chambermaid Products, Loxahatchee, FL, to cover corrective and preventive action, purchasing controls, nonconforming product, production/process controls and complaint handling, according to a...

Canadian manufacturer fails to conform with GMPs.
April 1, 2004... DynaMedics Corp., London, ON, Canada, was cited during an Oct. 22-23, 2003, inspection for alternating pressure mattresses that had no quality plan and no management representative appointed for ensuring that quality system requirements were...

FDA says Electra Therapeutic has poor quality system, lacks MDR procedures.
April 1, 2004... Poor quality system management was among several GMP deviations found at Electra Therapeutic Devices, Inc., Markham, ON, Canada, on Dec. 1, 2003. According to an April 5 warning letter, FDA determined that the repackager/relabeler of the...

Medical Measurements fails to establish quality procedures, design controls.
April 1, 2004... Lack of established procedures for the identification, documentation, validation or, where appropriate, verification, review and approval of design changes before their implementation were among violations that landed Medical Measurements,...

Meter manufacturer lacks procedures for finished device acceptance.
April 1, 2004... Per-Tech, Inc., Suring, WI, failed to establish and maintain procedures for finished device acceptance to ensure that each product run, lot or batch of finished device met acceptance criteria, according to a March 2 warning letter. The...