Validation Times articles from February 2005

Validation Times archives from February 2005

2006 FDA budget sees decline in biologic, drug inspections, but big boost for Office of Drug Safety; device audits even with '05.(Compliance/enforcement)
February 1, 2005... An analysis of FDA's FY 2006 budget request indicates the agency is increasing funding to improve the safety of marketed drugs, while decreasing the total number of inspections in most areas (see Table 1 below), except for Center for Devices...

WFI can now be produced by any method other than reverse osmosis under USP.(Water-for-injection)
February 1, 2005... PHILADELPHIA -- As of January, water-for-injection (WFI) can now be produced by any method that is superior or equivalent to distillation in the removal of chemicals and microorganisms under U.S. Pharmacopeia (USP) standards, whereas in the...

18 warning letters to drug makers since September cite CAPA citations, up to 80% of 483s contain CAPA non-compliance.(CAPA)
February 1, 2005... PHILADELPHIA -- At least 18 FDA warning letters issued to pharmaceutical manufacturers since September 2004 cite failures to institute corrective and preventative actions (CAPA) and between 30- 80% of 483s detail CAPA non-compliance, GMP...

Kiel Labs cited for Part 11 and OOS violations in 19-item 483.(Human drugs)
February 1, 2005... Kiel Laboratories, Gainesville, GA, received a 19-item 483 for allegedly violating FDA electronic records regulations (21 CFR Part 11), and for out-of-specification (OOS) result violations and validation deficiencies. Investigators Penny...

Old Hickory nets 19-item 483 for violations in calibration and cleaning of equipment.
February 1, 2005... Human and animal drug manufacturer Old Hickory Medicine Company in Andalusia, AL, received a 19-item 483 for numerous flaws in calibration and cleaning of equipment, as well as QC violations. Marvin Jones from the New Orleans District Office...

Mammography manufacturer served with 9-item 483 and warning letter for DHR, DMR violations.(Medical devices)
February 1, 2005... American Mammographics, Chattanooga, TN, did not establish a device master record (DMR) or procedures to maintain a proper device history record (DHR) for each batch, lot or unit, netting a nine- item 483 and a Nov. 25, 2003, warning letter for...

Ortho Technology receives 9-item 483 and warning letter for CAPA flaws, QS, MDR deficiencies.
February 1, 2005... Failure to document CAPAs, quality system problems, failure to verify conformance to specifications, and no MDR procedures led to the issuance of a nine-item 483 and an Oct. 16, 2003, warning letter for Ortho Technology, Tampa, FL. Investigator...

Quality system, CAPA, MDR, and validation flaws land 19-item 483 for Wright Medical Technologies.
February 1, 2005... Wright Medical Technologies, Arlington, TN, received a 19-item 483 because the firm did not ensure an "adequate and effective" quality system was in place, because CAPAs were not verified or validated "to ensure that the action is effective and...

Changes to manufacturing processes not validated at Lex.(Human drugs)
February 1, 2005... FDA investigator Jennifer Medendez visiting Lex, Additionally, Lex had never established the reliability Inc., Medley, FL, a manufacturer of various OTC and Rx drug products, found that the firm did not validate changes to the manufacturing...

Respi Care lacks validation for aseptic filling operations.
February 1, 2005... Respi Care Group of Puerto Rico, Caguas, PR, was cited, following a June 9- 17, 2004, inspection, for not validating its aseptic filling operations, in that media fills were not performed to assess the firm's aseptic technique. ...

BioHorizons cited for QS, complaint handling, CAPA issues.(Medical devices)
February 1, 2005... At an audit conducted Oct. 26-29 and Nov. 1-2, 2004, FDA found BioHorizons Implant Systems, Birmingham, AL, in violation of the GMP/Quality System regulations regarding its dental devices, including endosseous implants. According to the...

Cincinnati Sub-Zero did not re-validate process when deviation occurred.
February 1, 2005... FDA reviewed Cincinnati Sub-Zero Products, Cincinnati, a medical device manufacturing firm, on Nov. 8, 9 and 15, 2004, and determined that a validated process was not reviewed, evaluated or re- validated when changes or process deviations...

Manufacturer of nerve stimulator device did not establish design validation procedures.
February 1, 2005... Cyberonics, Inc., Houston, did not establish or maintain adequate procedures for validating its Vagus Nerve Stimulator device design, including design testing under actual or simulated-use conditions, according to a recently release warning...

Danlee's DHR deficiencies, lack of quality system draws warning letter.
February 1, 2005... Deficiencies in device history records as well as a failure to establish a quality system were among citations in a warning letter to Danlee Medical Products, Inc., Syracuse, NY. A six-month review of 11 of the firm's device history records...

Medical device reporting and complaint procedures faults cited at Synthes.
February 1, 2005... During a May 11-June 18, 2004, inspection, FDA found that Synthes Biomaterials Worldwide, West Chester, PA, violated MDR regulations as well as QS regulations covering complaint procedures. The company's products include the Norian XR...