Validation Times articles from March 2006

Validation Times archives from March 2006

Drug inspections up 3% from FY '04, but overall FDA audits drop 9% in '05.(Inspections)
March 1, 2006... FDA increased its inspections of pharmaceutical manufacturers by 3% in fiscal 2005, and a whopping 14.7% for veterinary products, but overall audits by the agency dropped 9% from fiscal 2004, according to data received from the Office of...

Firms scored 'low' if given a heads up on audits, inspector says.(Inspections)
March 1, 2006... ATHENS, GA -- Pharmaceutical firms getting pre-approval audits or any other inspection where they may know FDA is coming might not be getting 483s because the agency assumes firms had time to clean up any problems, Robert Coleman, FDA National...

ICH guidance not a 'cookbook' for industry, top GMP official tells Georgia meeting.(Quality systems)
March 1, 2006... ATHENS, GA -- The International Conference on Harmonization's (ICH) series of documents on quality systems--such as, ICH Q9 concerning Risk Management--are not designed to be a "cookbook" for managing risk, but to help industry structure...

Special 'cadre' under Pharmaceutical Inspectorate still in progress.(Inspections)
March 1, 2006... ATHENS -- FDA's Pharmaceutical Inspectorate, created two years ago under the Pharmaceutical GMPs for the 21st Century Initiative, is still trying to establish a "Cadre of highly-trained investigators who will have an integral role in the key...

Boehringer nets 12-item 483 for control procedures and batch failure reviews.(Human drugs)
March 1, 2006... Boehringer Ingelheim Vetmedica, Elwood, KS, received a 12-item 483 due to a lack of control procedures to validate process performance and inadequate review of batch failures. The company also received a warning letter for the violations dated...

Diversified nets 9-item 483 for lab test flaws, poor cleaning records.
March 1, 2006... A nine-item 483 was handed to Diversified Manufacturing Corp., Newport, MN, because drug products required to be free of objectionable microorganisms were not given appropriate lab tests. The firm also was written up for a lack of records...

CAPAs, cleaning, calibration cited in 14-item 483 for Ram Precision.(Medical devices)
March 1, 2006... Ram Precision Industries, Centerville, OH, a manufacturer of stainless steel parts for various medical devices, was slapped with a 14-item 483 because of undocumented corrective and preventive actions (CAPAs). Calibration and cleaning...

CBL cited in 3 483s for aseptic processing, media fills, sterility procedures.(Blood & biologics)
March 1, 2006... Chesapeake Biological Laboratories (CBL), Baltimore, MD, received three 483s recently that emphasized deficient aseptic processing areas, media fills not being completed on time and inadequate procedures to prevent microbiological...

Southern Meds cited for written procedures, control systems, media fills.(Human drugs)
March 1, 2006... An inspection conducted on Southern Meds Joint Venture, Biloxi, MS, on Aug. 3-5 and 11, 2005, documented serious violations of the Food, Drug and Cosmetic Act (FD&C Act) as pertains to compounded drugs. First, the Feb. 21 warning letter...

QS procedures, validation trip up Neuro-Fitness.(Medical devices)
March 1, 2006... An FDA-conducted inspection Aug. 17 and 25, 2005, determined that Neuro-Fitness, Fall City, WA, had made significant modifications to the design of its cranial electrotherapy stimulator by changing the mode of operation to 0.35 Hz, but the...

Oculus Optikgerate cited for design flaws and lack of quality audits.
March 1, 2006... During a Sept. 5-9, 2005, inspection, an FDA investigator determined that Oculus Optikgerate GmbH, Wetzlar, Germany--a manufacturer of Pentacam and Pachycam devices--was not in conformance with the current GMP requirements of the QS regulation....

Letter for Seecor for MDRs, complaint handling.
March 1, 2006... An FDA inspection conducted between Oct. 17 and 28, 2005, of Seecor, Mesquite, TX, determined the manufacturer of the Stat-Pace II Transesophageal Cardiac Pacer (external pulse generator) and the AC Fibrillator Model 2039 was not in conformance...

SOPs, design validation net letter for Shelhigh.
March 1, 2006... During inspections of Shelhigh, Union, NJ, from April 28 through May 16, 2005, and July 21 through Aug. 10, 2005, FDA investigators determined the manufacturer of Porcine Pulmonic Valve Conduits, Aortic Valve Conduits, Mitral Valve Conduits,...