Validation Times articles from March 2002

Validation Times archives from March 2002

Sterile drug recalls more than doubled in 2001; environmental monitoring blamed. (Environmental monitoring).
March 1, 2002... ORLANDO, FL -- Sterile drug recall trends increased in 2000 with a total of 50 drugs recalled for lack of sterility assurance and in 2001 with a total of 135 recalls for the same reason, FDAers told PDA's spring conference here March 11-13. ...

FDA, industry struggle to find common ground on impurities, skip testing, other issues. (Specifications).
March 1, 2002... ARLINGTON, VA -- FDA and industry need to find a middle ground on the amount of information the agency wants and companies are willing to present with regard to drug substance and drug product specifications. The problem was cited...

Design a clean room for maximum quality assurance. (Cleanrooms).
March 1, 2002... ORLANDO, FL -- While the cleanroom should prove to be grounds for sterility assurance, this room is the location where FDA sometimes finds discrepancies. Looking past the factors of personnel and cleaning practices, the design concept of a...

Validating disinfectant system with SOPs seen producing more fruit. (Cleanrooms).
March 1, 2002... ORLANDO, FL -- There may be more than one right way to help create a sterile environment, but successful measures rely on proper cleaning and disinfecting. "It is not a one-size fits all world," Elaine Kopis of Steris Corporation, St. Louis,...

ISO standard for cleanroom operations issued; could offer guidance on gowning, cleaning. (Cleanrooms).
March 1, 2002... BALTIMORE -- The International Standards Organization (ISO) has finalized ISO 14644-5 for Cleanroom Operations, a standard that also could give sterile drug and biologic manufacturers, plus some device manufacturers, guidance on gowning and...

Training personnel better can lead to lower microorganisms. (Cleanrooms).
March 1, 2002... ORLANDO, FL -- Establishing clear rules and an understanding of how the smallest deterrence from the path of correct procedure can compromise sterility assurance is probably the first step towards creating truly efficient employees, and thus...

Cardinal subsidiary popped on 483, evades warning. (Human drugs).
March 1, 2002... Chicago district investigators Alicia Mozzachio and Mark Jiminez came across problems with media fills and validation lapses during their March 2001 inspection of contract drug maker Automatic Liquid Packaging (ALP) of Woodstock, IL, but the...

Labeling error paves way for warning to Bio-Pharm. (Human drugs).
March 1, 2002... A potential recall prompted by a labeling mix-up prompted the Philadelphia district inspection of contract OTC drug maker Bio-Pharm of Levittown, PA, and investigator Edward McDonald and compliance officer James Illuminati wrote up the firm for...

FDA inks warning for shuttered reprocessing plant. (Devices).
March 1, 2002... Investigator Claudette Brooks of the Atlanta district undertook a two-day audit of device reprocessor Paragon Healthcare of Spartanburg, SC, and uncovered problems with failure to assess new inventory for reprocessability as well as for risk...

Amgen earns citations, but quick response rescues firm from warning letter. (Biologics).
March 1, 2002... Amgen, no stranger to tough inspections, landed a three-page 483 with hits for validation of a stability chamber and a filling process the firm tinkered with, but Amgen's compliance department quickly brought matters under control and the June...

Island Kinetics receives letter for failure to follow "basic requirements". (Human drugs).
March 1, 2002... Except for an unsigned product formula sheet for each of the firm's cosmetics and drugs, Island Kinetics of Phoenix, AZ, had no written procedures for production processes, according to a just-released Dec. 27, 2001, warning letter. ...

Letter cites fundamental QC shortcomings, other transgressions. (Human drugs).
March 1, 2002... Pfizer found itself on the business end of a Jan. 30 warning letter for its aseptic drug processing plant in Terra Haute, IN, which commenced with the blistering observation that its quality control unit was not up to the job "as demonstrated...

PDS fails to segregate systems, receives warning. (Human drugs).
March 1, 2002... Drug repackager Pharmaceutical Distribution Systems (PDS) of Montclair, VA, netted a Jan. 3 warning letter saying the firm did not employ separate facilities between April 16 and Nov. 16, 2001 for products with and without penicillin. The...

Premature device release lands Abbott in hot water. (Medical devices).
March 1, 2002... Investigators Nicholas Nance and Ricki Chase-Off of the Chicago district sorted through the Salt Lake City, UT, plant owned by Abbott Labs of Abbott Park, IL, and found the company released a thermodilution catheter prior to full approval of...

FDA declares simulated product not good enough for sterilization validation. (Medical devices).
March 1, 2002... Biomet Merck of South Wales, UK, which makes implantable orthopedic prostheses, was cited in a Feb. 19 warning letter for using a simulated product in a sterilization validation because the proxy device "did not go through the routine...

Insufficient documentation a stumbling block for hearing aid manufacturer. (Medical devices).
March 1, 2002... Dallas-based Hearing Aid Express felt the ping of a Feb. 22 warning letter that cited changes to a curing process for hearing aid shells, which lacked documentation. The Dallas district did not name the investigator handling the Dec. 18-21,...

Medical Accessories receives letter for validation faults. (Medical devices).
March 1, 2002... FDA's New Jersey district director, Douglas Ellsworth, kept his Feb. 4 warning letter to Medical Accessories of Trenton, NJ, to two pages, but managed to cram in five deviations, including failure to document validation of a heat-sealing...

Warning lists multiple validation transgressions. (Medical devices).
March 1, 2002... Investigator Ronald Weber of the Florida district handled the Dec. 10-12, 2001, inspection of Medicomp of Gainesville, FL, and found enough to justify a Feb. 6 warning letter hitting the maker of electrocardiograph monitors for failure to...

Design control a stumbling block for OPR. (Medical devices).
March 1, 2002... Gainesville, FL, is the site of another device maker receiving a warning letter from the Florida district, this one going to Optical Polymer Research, maker of various contact lenses, which took a shot on the Jan. 29 letter for lack of design...

Agency advises outside certification in light of weak design control procedures. (Medical devices).
March 1, 2002... FDA recommended that Western Enterprises of Westlake, OH, obtain outside certification after the Dec. 7-18, 2001, inspection disclosed design control procedures did not "describe in detail when and how design verification and validation will be...