Validation Times articles from July 2005

Validation Times archives from July 2005

FDA gives pharma companies regulatory relief as they implement PAT.(Process analytical technology)
July 1, 2005... BALTIMORE -- As companies integrate process analytical technology (PAT) into their existing systems to enhance understanding and control of their manufacturing processes, companies should not be overly concerned with generating "incriminating"...

Fast track facility construction more common in biotechnology industry.(Facility qualification)
July 1, 2005... PHILADELPHIA -- The demand for manufacturing facilities of larger scale is growing and experts at the Biotechnology Industry Organization (BIO) Convention held here June 19-22 agreed that bigger construction projects are being executed at a...

Re-validate system compatibility/stability after formulation and container changes.(Stability)
July 1, 2005... BETHESDA, IVID -- FDA has seen many cases where biotechology companies failed to re-validate their system compatibility and stability after making changes in their formulations or container-closure systems, officials told a California...

Validation proofs should be self-evident, Schering lawyer says.(Process validation)
July 1, 2005... NEW YORK -- A senior legal director at Schering-Plough said the industry must hold its validation processes to a higher standard. "Validation is not just running through your system three times, collecting a lot more data, and going to...

Centralization at Dey improved quality, and consistency enhanced document retrieval.(Training)
July 1, 2005... BALTIMORE--Dey Labs, Napa, CA, implemented a centralized GMP training program in 2004, which led to better, streamlined training, more efficient document retrieval, document standardization, and enhanced FDA compliance, said Dey's Al Erario,...

Quality/lab control inspection nets firm 2-item 483 for lab control deficiencies.(Human drugs)
July 1, 2005... An inspection covering quality and laboratory systems resulted in a two-item 483 and revealed laboratory controls that lacked "the establishment of scientifically sound and appropriate test procedures" for Janssen Pharmaceutica, Titusville, NJ,...

Medical Measurements hit in 14-item 483 for quality system failures, equipment calibration, CAPAs.(Medical devices)
July 1, 2005... The management at Hackensack, NJ-based Medical Measurements did not "ensure that an adequate and effective quality system has been fully implemented and maintained," and also was cited for improper equipment calibration and poor CAPA...

Pragmatic Materials hit for expiration dating and repackaging nonconformities.(Human drugs)
July 1, 2005... During an inspection Feb. 8, 15 and 18, FDA determined that Pragmatic Materials, Solon, OH was in violation of current GMP regulations, netting a June 17 warning letter for the API [active pharmaceutical ingredient] repackaging and relabeling...

American Thermal cited for validation process flaws.(Medical devices)
July 1, 2005... A June 14 warning letter was sent to American Thermal Instrument, Dayton, OH, following an April 19-21 inspection, because the firm was not in conformance with the QS regulation. The company manufactures liquid crystal forehead thermometers,...

QS flaws revealed at Arrow International.
July 1, 2005... An inspection Dec. 2-22, 2004, at Arrow International, Reading, PA, showed the manufacturer's neonatal catheters violated current GMP requirements of the QS regulations. The June 16 warning letter stated that the firm failed to submit an...

Biolmagene marketed product online without PMA.
July 1, 2005... After reviewing the company's website, FDA determined Biolmagene, San Jose, CA, was marketing the product, Pathiam, without a PMA, netting the company a May 25 warning letter. According to the website, Pathiam is a "hardware-independent,...

Validation failures uncovered at Bioteque America.
July 1, 2005... Bioteque America, Langhorne, PA, was inspected May 1, and FDA concluded that the specifications developer of gynecological uterine devices--such as, cervical dilators, endometrial suction curettes, curelles, vabra aspirators, cytology brushes,...

Investigation failures net letter for CrestLab.
July 1, 2005... An April 21-28 inspection determined that CrestLab (dba Kingswood Labs), Indianapolis, did not conform to the requirements of the current GMP of the QS regulations for its medical device product Moi-Stir Oral Swabstick. The June 29 warning...

Global Manufacturing tripped up by QS system and quality audits.
July 1, 2005... A Jan. 5-6 inspection of Global Manufacturing & Engineering, Ocean Springs, MS, found that the contract manufacturer of metal bone screws, connectors and hooks, was not in conformance with the current GMP requirements of the QS regulations. ...

Repackaging flaws noted for Lake Erie Medical.
July 1, 2005... A June 21 warning letter was issued to Lake Erie Medical and Surgical, Temperance, MI, because a Jan. 25-Feb. 14 inspection of the firm's Quality Care Products drug repackaging site found deviations from the current GMP regulations. ...

CAPAs and investigation errors cited for Lee Medical.
July 1, 2005... An FDA inspection conducted Feb. 3, 7, 11 and 17, and March 3, 11 and 14, of Lee Medical International, Harahan, LA, showed that the company's various dialysis and catheter kits were adulterated because they deviated from the current GMP...

Medtronic Emergency short on quality audits/reports, process analysis.
July 1, 2005... A Feb. 23, March 2-4, 7, 9-11, 14-18, 21-25, 28 and 31 inspection of Medtronic Emergency Response System, Redmond, WA, determined that the firm, which manufactures the LifePak defibrillator, was not in conformance with the current GMP...

No complaint follow-up earns citation for Millennium Dental.
July 1, 2005... A June 7 warning letter was issued to Millennium Dental Technologies, Cerritos, CA, because the manufacturer of the PerioLase periodontal laser was not in conformance with the current QS regulations for finished devices. In an inspection...

Non-submittal of PMA, design-change errors cited for Pascal.
July 1, 2005... After a December 2004, inspection of Pascal Co., Bellevue, WA, FDA concluded the firm was in violation of the current GMP/Quality System regulation, which resulted in the issuance of a May 24 warning letter. Pascal manufactures and...

Spectronics fails to prepare/maintain DMR.
July 1, 2005... A May 19 warning letter was sent to Spectronics Corp, Westbury, NY, because an April 5, 6 and 12 inspection determined the firm was not in conformance with the QS regulations. For example, the manufacturer of x-ray autoradiography cassettes...