Validation Times articles from November 2005

Validation Times archives from November 2005

Validation, sterility assurance, OOS top regulatory actions in 2005; Able Labs case seen triggering more audits.(Compliance/enforcement)
November 1, 2005... WASHINGTON -- While the Center for Drugs issued only 14 warning letters for finished drug product makers in fiscal 2005 (which ended Sept. 30), validation, lack of sterility assurance and inadequate lab investigations led regulatory actions,...

Presence of particulate matter in vials top reason for product recalls, Pfizer executive reports at PDA conference.(Recalls)
November 1, 2005... BETHESDA, MD -- One of the most common reasons for a drug recall is the presence of particulate matter in sample vials, according to a 2002 CDER report on 437 drug recalls. Consequently, FDA increasingly has been challenging firms' visual...

FDA's Winkle says new CMC review processes crucial to movement toward 'desired state'.(CMC)
November 1, 2005... BALTIMORE -- Deputy Commissioner for Operations Janet Woodcock, M.D., recently defined the "desired state" of pharmaceutical development as a "maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces...

Low-end visual threshold for manual visual inspections needs to be defined.(Visual inspection)
November 1, 2005... BETHESDA, MD -- Inspections for visible particles have been confronted by the same dilemma for decades: Because visible particles have no defined size limits in any government regulations, how can a company make decisions to accept or reject...

Effective risk management should be trained into employees, integrated into existing operations, documented.(Risk management)
November 1, 2005... BALTIMORE -- "Training of industry and regulatory personnel in risk management and assessment provides for greater understanding of decision-making processes and builds confidence in quality risk-management outcomes," said Susan Banks-Williams,...

Validation and media fill flaws trip up Allergan.(Human drugs)
November 1, 2005... A lack of validation and integral media fill units that were not being incubated were noted in a pre-approval inspection of Allergan, Waco, TX, which resulted in a seven-item 483. Dallas District Office Investigators David Beltran and Daniel...

Encore Medical receives 9-item 483 citing quality system; audits, unvalidated design changes.(Medical devices)
November 1, 2005... Encore Medical, Sarasota, FL, failed to implement an effective quality system and quality audits and did not establish procedures "for the validation or verification, review and approval of design changes," netting the firm a nine-item 483....

9-item 483 for Hamilton Medical, citing CAPAs and quality audits.(Medical devices)
November 1, 2005... Hamilton Medical AG, Bonaduz, Switzerland, received a nine-item 483 for CAPA procedures not being implemented and quality audits not being conducted regularly. This was a full performance audit between the U.S. and EU [European Union] under the...

Diversified Manufacturing fails to validate cleaning of equipment.(Human drugs)
November 1, 2005... Following a March 4, 7 and 10 inspection of Diversified Manufacturing Corp., Newport, MN, FDA determined that the firm was not in compliance with GMPs, chiefly, cleaning validation. The Oct. 20 warning letter noted violations that included...

Process validation and lack of design verification procedures cited for American L.V. Products.(Medical devices)
November 1, 2005... During a July 29-Aug. 17 inspection of American L.V. Products, Hanover, MD, FDA determined that the manufacturer of the AIV Ultrasound Fetal Monitor Transducer Models FM10833 and FM10834 was not in compliance with the current GMP/QS regulation....

B. Braun Medical fails identify actions to prevent recurrence of nonconforming cardiac devices.(Medical devices)
November 1, 2005... A May 9-23 inspection conducted at B. Braun Medical's Cherry Hill, NJ, location determined that the manufacturer of cardiac devices was not in conformance with current GMP requirements of the QS regulation. For example, the Oct. 12 warning...

No procedures to control product design trips up Precision Converters.
November 1, 2005... During an Aug. 15-31 inspection of Precision Converters in Dallas, FDA inspectors found the firm was not in conformance with the current GMP requirements of the QS regulation. Violations cited in the Oct. 18 warning letter included failure...

Quantum Skincare receives letter for lack of CAPA procedures.
November 1, 2005... After a May 31 June 6 inspection, FDA determined that Quantum Skincare, Ringgold, LA, which manufactures infrared lamps, was not in compliance with the current GMP of the QS regulation. The Oct. 31 warning letter noted failure to establish...

Lack of preventive maintenance, DMRs cited for Ram Precision.
November 1, 2005... An Aug. 16-18 inspection of Ram Precision Industries, Centerville, OH, found that that the device manufacturer was not in compliance with the current GMP requirements of the QS regulation. In an Oct. 17 warning letter, the agency stated...