Validation Times articles from February 2008

Validation Times archives from February 2008

Future drug pre-approval inspections to focus on better communication between FDA divisions.(Inspections)
February 1, 2008... WASHINGTON -- The future of the pre-approval inspections (PAI) at the Center for Drugs will focus on enhancing communications between Center for Drugs review divisions, the Office of Compliance and field district offices on application-specific...

Individuals always named in consent decrees; practice strongly founded in case law.(Compliance/enforcement)
February 1, 2008... WASHINGTON -- FDA always names individuals in civil consent decrees against negligent manufacturers, and case law strongly supports personal responsibility and accountability, according to Annemarie Kempic, Associate Deputy for Litigation...

Civil monetary penalties used when seizure, injunction, prosecution are inadequate.(Civil penalties)
February 1, 2008... WASHINGTON -- FDA's Center for Devices initiates civil monetary penalties--with a maximum amount for each violation of $16,500--on negligent medical device companies when FDA has given repeated prior notice of serious problems in 483s, warning...

CPG for un-cleared medicines focuses on safety risks, lack of effectiveness, fraud.(Unapproved drugs)
February 1, 2008... WASHINGTON -- Center for Drugs' Marketed Unapproved Drugs compliance policy guide (CPG) that was introduced in June 2006 focuses on drugs that have safety risks, lack evidence of effectiveness, are fraudulent, directly compete with an approved...

116 medical device warning letters issued in FY '07 with focus on GMP, QS.(Medical devices)
February 1, 2008... WASHINGTON -- FDA issued 116 medical device warning letters in fiscal 2007, with the overwhelming number being GNP related, a private attorney told FDLI's meeting here. Jennifer Bragg, a senior associate with the law firm King & Spalding,...

IVX slapped with 15-item 483 for contamination procedures.(Human/animal drugs)
February 1, 2008... IVX Animal Health, Saint Joseph, MO, was hit with a 15-item 483 in a recent GMP audit because procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not followed. The report was written...

CAPA and quality audit flaws cited for HaloSource.(Medical devices)
February 1, 2008... HaloSource, Raymond, WA, was the recipient of a three-item 483 because it did not implement procedures for corrective and preventive actions (CAPAs), and for inadequate quality audits. The EIR stated that the firm is a medical device...

Validation design for Medtronic Neurological cited in 9-item 483.(Medical devices)
February 1, 2008... Medtronic Neurological, Minneapolis, MN, was slapped with a nine-item 483 because its medical device designs were not validated using production units or their equivalents. The inspection was conducted by investigators Kellie Westerbuhr and...

Sterilmed not cited in FDA report.(Medical devices)
February 1, 2008... Sterilmed, Maple Grove, MN, a reprocessor of medical devices, passed a routine GMP inspection recently that reviewed sterilization validation, cycle data, ETC residual testing and bioburden testing, and no 483 was issued. The audit was...

American Hormones warned for contamination problems.(Human drugs)
February 1, 2008... From Dec. 14-Dec. 29, 2006, FDA inspected American Hormones, Wappingers Falls, NY, which produces human prescription drugs including testosterone lipoderm gel, thyroid (T4/T3) capsules, pregnenolone capsules, DHEA (dehydroepiandrosterone)...

Lyne Labs warned for failure to meet specs, QC.(Human drugs)
February 1, 2008... An inspection of the drug manufacturing facility at Lyne Laboratories, Brockton, MA, from Sept. 20-Oct. 5 found significant deviations from FDA's GNP regulations for finished pharmaceuticals. Lyne Laboratories, the Jan. 17 warning letter...

Tomita Pharma hit with letter for lab system flaws.(Human drugs)
February 1, 2008... The inspection of Tomita Pharmaceutical, Tokushima, Japan, July 31-Aug. 2, revealed significant deviations from GMPs in the manufacture of active pharmaceutical ingredients (APIs). These GNP deviations caused the company's APIs to be...

Software firm warned for CAPAs and quality audits.(Medical devices)
February 1, 2008... During an inspection of ConnexMD, Seattle, WA, which manufactures the EchoConnex Communicator software (Digital-Image Storage and Review) that is used in hospitals, imaging centers and office practices, FDA found the devices were adulterated...