Validation Times articles from December 2006

Validation Times archives from December 2006

PhRMA supports move to all-electronic drug applications; questions arise at hearing about re-visiting Part 11 guidance.(Electronic records)
December 1, 2006... ROCKVILLE, MD -- The Pharmaceutical Research and Manufacturers of America (PhRMA) "fully endorses a planned move to an all-electronic drug application submission process," but stresses the need for a well-managed development and implementation...

Generics lobby sees industry faring well in compliance oversight from new Congress.(Compliance/enforcement)
December 1, 2006... The generic drug industry's chief lobbyist in Washington sees no real threat from the new Democratic-controlled Congress when it comes to conducting oversight and investigations of FDA/industry GMP compliance and does not see this having a...

Pharma firms taking back seat to other industries in terms of validating packages.(Packaging)
December 1, 2006... SAN DIEGO -- In terms of designing systems for quality, pharma is playing "catch up" compared to other manufacturing industries, a QA consultant told an audience here Dec. 6. Jackelyn Rodriguez, president of Monarch Quality Systems...

Process flow highlights gaps, errors in FDA-regulated facilities.(Process validation)
December 1, 2006... SAN DIEGO -- Flow charts are ideal tools to help developers and manufacturers conduct gap analyses "between what you are doing and the regulatory requirements," said a GMP consultant here Dec. 6. Medical device consultant John E. Lincoln of...

GMP auditor from Sanofi's Hungarian subsidiary identifies means to minimize risks with EU facilities.(Process validation)
December 1, 2006... SAN DIEGO -- Tailoring process validation approaches for unproven or familiar facilities was presented from a European perspective here Dec. 6. Katalin Nemak, Ph.D., quality and compliance GMP Auditor with Chinoin, a Budapest, Hungary,...

Drug manufacturer slapped with 5-item 483 for procedures to prevent contamination.(Human drugs)
December 1, 2006... Bioniche, Teo, County Galway, Ireland, was slapped with a five-item 483 due to not following procedures to assure that products purported to be sterile are not contaminated with microbiological organisms, and for lack of control procedures to...

CareFore hit with 10-item 483 for lack of design and development plan.(Medical devices)
December 1, 2006... CareFore Medical, Olathe, KS, was the recipient of a 10-item 483 because it did not establish a proper design and development plan. Only the 483 was available at press time. A Jan. 10 warning letter also was issued focusing on quality...

Utah Medical Products receives two 483s; lawsuit ensues.(Medical devices)
December 1, 2006... Utah Medical Products (UTMD), Midvale, UT, was hit with two 483s in recent inspections that cited quality audits, software validation, CAPAs, procedures for nonconforming product, equipment cleaning and other quality problems. The company...

Identity testing, other GMP issues snare Benchmark Medical.(Human drugs)
December 1, 2006... FDA inspected Benchmark Medical, Salt Lake City, April 10-13, and found the drug manufacturing facility in violation of several GMP issues and not having NDAs for several products. According to the Nov. 3 warning letter from FDA's Denver...

Direct dispensing cited for labeling issues.(Warning Letter Analysis)
December 1, 2006... FDA investigators Amber Wardwell and Jennifer Menendez inspected Direct Dispensing, Miami, FL, a prescription and OTC capsule and tablet repacking and relabeling facility, on Sept. 12-16, 2005, and February 2-14 and March 28, 2006. Labeling and...

Unapproved ingredient nets letter for Health Dimensions.(Warning Letter Analysis)
December 1, 2006... On Aug. 7, FDA determined that Health Dimensions was compounding a drug in an orally administered dosage form with an unapproved active ingredient. The agency expressed concern regarding public health risks associated with the unnamed compound...

Unnamed Italian device firm warned for misbranding.(Medical devices)
December 1, 2006... This warning letter regarding an inspection of a manufacturing plant for endosseous implant abutments and dental attachments, June 19-22, in Bologna, Italy, did not name the firm. The Nov. 21 warning letter, indicating that FDA had found...

Dupaco issued warning letter citing CAPAs and failure to meet specs.(Medical devices)
December 1, 2006... A Sept. 20 FDA investigation determined that Dupaco, Oceanside, CA--a manufacturer of blood/fluid warming sets and other general hospital use products--was not in conformance with the current GMP requirements for medical devices set forth in...

Gyrus written up for nonconforming procedures.(Medical devices)
December 1, 2006... An August 14-23, FDA investigation determined that Gyrus ENT, Barlett, TN, a manufacturer of the Diego Hand Piece intended for general nose, throat, and head/neck procedures, was not in conformance with the current GMP requirements of the QS...

M & S Acquisition slapped with letter for quality problems and validation.(Medical devices)
December 1, 2006... M & S Acquisition Co, dba Miltronics & Skye, Cincinnati, OH, was the subject of a Sept. 11- 27 FDA investigation. In it, the firm's facility in Mentor, OH, which produces orthopedic implantable devices, including lumbar bone screws, rods, nuts...

Perkins Electronics receives letter for device design validation.(Medical devices)
December 1, 2006... An FDA investigation Sept. 5-8, 11, 12 and 25, determined that Perkins Electronics, Dallas, a manufacturer of video-enhancement units (Fluoro Fade and Spirit), video up scan/down scan converters, medical video recorders/players, video matrix...

Failure to verify products meet specs nets letter for Skytron.(Medical devices)
December 1, 2006... During a July 11-12 investigation, FDA determined Skytron, Grand Rapids, MI, was not in conformance with the current GNP requirements of the QS regulation. Violations included in the Nov. 29 warning letter included failure to inspect, test...

Trionix Research Laboratory hit with warning letter for CAPAs.(Medical devices)
December 1, 2006... An FDA investigation July 25 through Aug. 9, determined that Trionix Research Laboratory located in Twinsburg, OH, was not in conformance with the current GNP requirements of the QS regulation. Violations included in the Nov 4 warning...