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Packager slapped with 4-item 483 for failing to follow protocol during several validation studies.
Carton Services, Norris, TN, was hit with a four-item 483 because it did not follow protocol during validation studies.
According to FDA documents, Carton Services manufactures paperboard cartons, some of which contain pharmaceutical or dietary supplement labeling. The firm also performs some repackaging and relabeling of pharmaceutical and dietary supplement products.
During validation, the FIR stated, protocol procedures "were not always followed and some failures to meet acceptance criteria were noted." The final report was approved even though some follow-up actions and revalidations were required, the report continued. Also, "no formal controls are in place to assure these follow-up actions will be completed," the FIR stated. Next, the final report concluded that an undisclosed machine speed had not been documented.
According to the FIR "the various protocol documents provided very little information on how equipment was to be set up and speeds at which equipment was to be run during the OQ [operational qualification] study." Also, Maticka wrote that he "asked what set-up instructions the operators had to work with at the time the OQ study was performed. Management stated they did not have anything in writing. This was considered objectionable."
The FDAer also cited Carton Services because PQ [performance qualification] batches were released by concurrent validation, although the company's procedures for process validation "describe no ...
- Carton Services slapped with 4-item 483 for failing to perform required...
- Newspaper article from: Inspection Monitor September 1, 2005 700+ words
...District Carton Services, Norris...stated that Carton Services manufactures...released by concurrent validation, although...one of the concurrent validation lots was...of sops. Carton Services did not respond...
- Edward Carton is dead at 59.(CALIFORNIA)(Trentadue Winery)(Obituary)
- Magazine article from: Wines & Vines December 1, 2007 700+ words
...Mazzocco Vineyards, and was part owner of Four Vines Winery. He joined Trentadue in 2005. He's survived by his wife, Barbara, a daughter and son-in-law, and his brother, Richard Carton. Services were held at Trentadue on Oct. 26.
- Unisource Worldwide Inc.(People Update)
- Magazine article from: Official Board Markets January 26, 2008 700+ words
...supplies sales and business development efforts in the Columbus and Cincinnati, Ohio, markets. Hoeppner has 10 years of experience in the printed folding carton segment, including managing an Ohio sales territory for Carton Services Inc.
- 47% of biologic 483s cite process faults; validation in retro urged.
- Newspaper article from: Validation Times Lawrence, Terry February 1, 2001 700+ words
...retrospective validation, and concurrent validation, if necessary, but consult with...Jan. 29, there also is room for concurrent validation. He said most of these 483 citations...retrospective validation and only allows concurrent validation for certain products, such steps...
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...category. This process is also termed a "concurrent validation" study. The benchmarks used in Career...continuous validation and development using concurrent validation. "Concurrent validation" is the American Psychological Association...
- Validation services and studies. (News From Assessment and Evaluation).
- Magazine article from: Nursing Education Perspectives March 1, 2002 700+ words
...Assessment and Evaluation (brose@nln.org). The NLN is also soliciting schools interested in participating in a concurrent validation study for its Critical Thinking in Clinical Nursing Practice Exam and either the California Critical Thinking...
- Lilly receives nine-item 483 for validation deficiencies, SOP deviations.(Human...
- Newspaper article from: Validation Times November 1, 2003 700+ words
...testing would be updated. He added that "these lots are manufactured infrequently. Therefore, the three-lot concurrent validation will continue to be part of the Quality Plan to be completed once two additional lots of material per item become...
- ASE Establishes Cadence Design Flow to Provide High-Performance IC Packaging...
- Press release article from: Business Wire November 21, 2002 700+ words
...for the interconnect through pre-layout exploration, constraint-driven interconnect implementation, and concurrent validation. "IC packaging is the critical link in a silicon-to-package-to-board design flow, which can mean...
- Catalytica nets warning letter from one-page 483.(Catalytica Phrmaceuticals...
- Newspaper article from: Inspection Monitor April 1, 2000 700+ words
...January 1998. FDA also commented that, while the firm's batch-by-batch release procedure "appears to be concurrent validation," it nonetheless expected to see a timetable for completed validation work. In an Aug. 11 letter to the...
- The validity of the Brief Michigan Alcohol Screening Test (bMAST) as a problem...
- Magazine article from: Journal of Studies on Alcohol and Drugs Connor, Jason P. Grier, Maree Feeney, Gerald F.X. Young, Ross McD. September 1, 2007 700+ words
...best 25 MAST items (Pokorny et al., 1972, p. 343) and acceptance of Selzer's (1971) weighted items. Concurrent validation was provided by zero-order correlations between the bMAST and MAST following a single administration of the...
Source: HighBeam Research, Packager slapped with 4-item 483 for failing to follow protocol...