Validation Times articles from June 2005

Validation Times archives from June 2005

FDA hopes to emulate pre-IND, pre-NDA meetings for CMC reviews; workshop slated for fall, pilot to follow.(CMC)
June 1, 2005... WASHINGTON -- Office of New Drug Chemistry Director Moheb Nasr, Ph.D., hopes that his group's efforts to develop a "quality overall summary" and reform the review of chemistry, manufacturing and controls (CMC) sections of NDAs will become more...

European directive may be discouraging U.S. manufacturers from renovating API facilities, doing clinicals; assay validation costs higher?(International)
June 1, 2005... PHILADELPHIA -- One year in, European directive 2001/20/EC's bearing on the global pharmaceutical industry has not fully been determined, but experts, such as, Susan Jones, Ph.D., senior consultant with Bioprocess Technology Consultants in...

Ignorance no defense against FD&C Act violations, top FDA litigator says.(Compliance/enforcement)
June 1, 2005... PRINCETON, NJ -- When in doubt, check it out. That was the resounding message Eric Blumberg, deputy chief counsel for litigation at FDA, had for attendees of the Pharma-Biotech-Device Colloquium June 6-8. Blumberg sought to drive home...

Schering-Plough admits 'starting over' following consent decree; root-cause analysis helpful.(Consent decrees)
June 1, 2005... PRINCETON, NJ -- A VP from the pharmaceutical company that paid one of the largest manufacturing fines in FDA history admitted having to overhaul their entire operations to get back on track, and noted that using root-cause analysis was one...

Biotech firms need to start eyeing QA, manufacturing capability in Phase I, says Genentech VP.(Biotech)
June 1, 2005... PRINCETON, NJ -- A manufacturing expert at one of the world's top biopharmaceutical companies said production planning for therapeutic proteins needs to begin in Phase I, although many fledgling biotech startups don't know if they have a...

Raw materials, particularly from Pacific Rim, plus documentation to get closer look.(Compliance/enforcement)
June 1, 2005... PRINCETON, NJ -- A former assistant U.S. attorney who prosecuted major pharmaceutical fraud and GMP cases said FDA is scrutinizing raw materials, such as, APIs from the Pacific Rim, and deviation documentation. "Companies need to start...

No 483 for Cardinal Health, process validation issue observed.(Human drugs)
June 1, 2005... Cardinal Health, Winchester, KY, escaped getting a 483 in a recent inspection, but Investigator Kathleen Culver from FDA's Cincinnati District Office noted one issue regarding process validation from an undisclosed type of tablets. ...

Staar Surgical cited in 483 for vendors not validating raw materials.(Medical devices)
June 1, 2005... A five-item 483 for Staar Surgical, Monrovia, CA, cited the maker of ophthalmic devices for failing to have sufficient oversight of vendors related to the validation of raw materials. Investigators Deborah Greco and Trudy Papson from the...

OOS results, media hold-time specifications, flawed validation reports net IDEC 10-item 483.(Biologics)
June 1, 2005... IDEC Pharmaceuticals, San Diego, received a 10-item 483 for out-of-specification (OOS) results, a lack of data to support media hold-time specifications and validation report problems. Investigator Mariza Jafary from Center for Biologics...

Alcon cited for neglecting CAPA procedures and complaint handling.(Medical devices)
June 1, 2005... An FDA audit of Alcon Labs, Orlando, FL, performed from Jan. 10-18, found significant violations of the QS/GMP rules regarding the company's LADARVision 4000 Excimer Laser System. The April 15 warning letter cited Alcon for neglecting to...

Boston Scientific lacks validation and management controls.
June 1, 2005... A March 9-April 7 inspection of Boston Scientific, Natick, MA, revealed deviations involving three different types of the implantable Vaxcel Low Profile Infusion Ports. These devices did not conform to the device QS regulations, FDA noted in a...

C&E GP Specialists lacks complaint-handling system.
June 1, 2005... An inspection conducted Jan. 26 and Feb. 8 determined that C&E Gp Specialists, San Clemente, CA, was not in conformance with QS regulations, resulting in a May 12 warning letter. The letter noted that the firm, a manufacturer of gas...

QS system trips up Digicare; internal audit, software validation flaws also noted.
June 1, 2005... A Jan. 25-28 inspection of Digicare Biomedical Technology, Boyton Beach, FL, noted violations of the QS regulation. According to the April 26 warning letter, the firm's management failed to review the suitability and effectiveness of the...

Electrologic of America written up for CAPAs, audits, training.
June 1, 2005... An FDA inspection performed March 15-18 and 22 netted a May 9 warning letter for Electrologic of America, Dayton, OH, a maker of electrical muscle stimulation stationary bicycles, specifically, the StimMaster Galaxy model. For example, the...

Pace Tech cited for personnel issues, CAPAs.
June 1, 2005... Pace Tech, Clearwater, FL, received an April 29 warning letter for non-conformance with QS regulations and MDR requirements. The Jan. 24-26 inspection revealed several deviations for the manufacturer of stationary and portable patient...

Telex receives letter for DHRs, MDRs.
June 1, 2005... A March 23-April 1 inspection of Telex Communications, Burnsville, MN, netted a May 23 warning letter due to violations of the QS regulations and MDR requirements. Violations for the auditory training manufacturer included failure to...