Validation Times articles from August 2007

Validation Times archives from August 2007

Dingell bill would boost food and drug inspections in FY 2008-2012, including APIs sourced from overseas.(Imports/inspections)
August 1, 2007... House Energy and Commerce Committee Chairman John Dingell (D-MI) plans to introduce a bill to levy $300 million in drug user fees for each fiscal year in the period 2008-2012, which would be allocated to inspections of imported drugs, including...

Another Able Labs executive found guilty of falsifying drug records.(Compliance/enforcement)
August 1, 2007... Two years ago, the generic pharmaceutical manufacturer Able Laboratories imploded because of falsifying laboratory results and failing to report adverse events to FDA, among other violations. In August the fallout continued. Vithal...

Negotiate with FDA nature of starting materials to limit liability: attorneys.(APIs)
August 1, 2007... Drug manufacturers would be wise to sit down with FDA review chemists and "negotiate the starting material you want" for APIs, two attorneys with expertise in API compliance told an ExpertBriefings.com Aug. 7. Walt Linscott, Chair, Life...

Warning letters focus on CAPAs, senior management inattention to quality.(CAPAs)
August 1, 2007... Major trends in recent warning letters issued by FDA include senior management inattention to quality issues, failure to provide adequate staff training and poor corrective and preventive action (CAPA) programs, a noted FDA expert and attorney...

Validation process problems net 7-item 483 for Actavis Pharma.(Human drugs)
August 1, 2007... Actavis/Purepac Pharmaceutical Co., Elizabeth, NJ, received a seven-item 483 following a 2006 inspection because the responsibilities and procedures applicable to the quality control unit were not fully followed, including products were not...

8-item 483 to Canfield for contaminated equipment and utensils.(Human drugs)
August 1, 2007... Canfield, C.R. & Co., Edina, MN, was slapped with an eight-item 483 because equipment and utensils were not sanitized at appropriate intervals to prevent contamination. Investigator Marie Fadden from the Minneapolis, MN, District Office...

Leiner Health Products cited for Part 11 and stability testing.(Human drugs)
August 1, 2007... Leiner Health Products, Fort Mill, SC, received an 18-item 483 in a recent audit because of inadequate controls over computer systems, in violation of FDA's electronic/signature records rule (21 CFR Part 11), and for failure to utilize results...

First priority fails to review discrepancies.(Human drugs)
August 1, 2007... An inspection of First Priority, Chicago, IL, confirmed that it was not operating in compliance with GMPs for the manufacture of its pharmaceuticals. In addition it is manufacturing "Purple Lotion Wound Dressing" as a new animal drug without an...

Firm fails to properly document CAPAs.(Human drugs)
August 1, 2007... FDA inspected Gebauer, Cleveland, OH, as a result of the firm's recall of its hydoflurocarbon (HFC) products and as a follow-up to an earlier March 2007 inspection, which also resulted in the recall and discontinued manufacture of the firm's...

Lab written up for lack of conformance to specs.(Human drugs)
August 1, 2007... During an inspection of Pharmaceutical Laboratories and Consultants, Des Plaines, IL, a contract testing lab, FDA documented significant deviations from GMPs regarding the company's testing of Rx and OTC drugs, according to a July 25 warning...

Pulse Biomedical cited for design change documentation.(Medical devices)
August 1, 2007... A July 30 warning letter cited Pulse Biomedical, Norristown, PA, the manufacturer of the QRS-Card Electrocardiograph (ECG) Machine with Blue Tooth (BT) Interface Technology for methods used in, or the facilities or controls used of its...

Sunoptic cited for several validation flaws.(Medical devices)
August 1, 2007... During an inspection of Sunoptic Technologies, Jacksonville, FL, FDA determined that the methods used in or the facilities or controls used for the manufacture, packing, storage or installation of the firm's products, Dental Probes and light...