Validation Times articles from August 2005

Validation Times archives from August 2005

CBER creating new analytical technologies to better weed out impurities in biotech products, FDAer tells WilBio.(Impurities/analytical methods)
August 1, 2005... MCLEAN, VA -- The Center for Biologics is developing new analytical technologies to improve the safety, purity and potency of biological products that will more accurately measure the amounts of preservatives, metals, stabilizers, adjuvants,...

Late-stage studies seen necessary and even helpful for approval, CASSS told.(Stability)
August 1, 2005... BETHESDA, MD -- A conference of FDA officials and industry scientists agreed here that late-stage stability studies, including stressed or accelerated studies, are not only needed for well-characterized biotech products, but can help show...

Roundtable, communication initiatives begun to improve global flu vaccine pipeline: CBER director.(Vaccines)(Panel Discussion)
August 1, 2005... MCLEAN, VA -- FDA learned multiple lessons from last year's flu vaccine shortage in the U.S., including the need to create more effective information-sharing agreements with foreign authorities pre-and post-licensure; to better encourage global...

Effective early clinical stability program has special needs due to limited time, product history and immature assay, HGS scientist reports to CASSS.(Stability)
August 1, 2005... BETHESDA, MD -- An early clinical stability program is special because time is limited, assays are immature, the formulation is non-optimized and product history is limited, noted Thomas Spitznagel, a scientist at Human Genome Sciences,...

Respi Care slapped in 13-item 483 for validation flaws in multiple systems.(Human drugs)
August 1, 2005... Respi Care Group of Puerto Rico, Caguas, PR, received a 13-item 483 for violations involving its systems for laboratory, production, quality, and equipment and facilities. A Dec. 20, 2004, warning letter also was issued six months after...

The Master's Miracle receives massive 79-item 483 for validation, QC problems.
August 1, 2005... Dozens of failures in validation and GMPs resulted in a 79-item 483 for The Master's Miracle, Maple Grove, MN. Investigator Sharon Thoma from the Minneapolis District Office conducted the audit. The inspection resulted in the issuance of a May...

23-item 483 issued to Advanced Bionics for quality audits, process validation and risk analysis faults.(Medical devices)
August 1, 2005... Inadequate procedures for conducting quality audits, a process that was not re-validated following deviations and incomplete risk analysis netted a 23-item 483 for medical device manufacturer Advanced Bionics Corporation, Irvine, CA. The...

GMP deficiencies noted at ACS Dobfar.(Human drugs)
August 1, 2005... An FDA inspection conducted March 14-24 of ACS Dobfar, Milan, Italy, discovered several GMP deficiencies, according to a July 21 warning letter, which noted that similar deficiencies were uncovered during an earlier May 2002 inspection. ...

Cape Drugs cited for compounding medicines with domperidone.
August 1, 2005... On Feb. 25, a Special Agent with FDA's Office of Criminal Investigations determined that Cape Drugs, Annapolis, MD, was compounding pharmaceuticals containing domperidone--an unapproved drug that is not recognized to be safe and effective. The...

BioMerieux cited for CAPAs and QC issues regarding in vitro diagnostics.(Blood/biologics)
August 1, 2005... A March 15-24 inspection of BioMerieux, Durham, NC, determined that the manufacturer of in vitro diagnostics was not in conformance with the current GMP requirements. The July 29 warning letter noted that the company failed to establish...

Greer Labs products fail to meet GMP standards.
August 1, 2005... During a Feb. 14-March 3 inspection of Greer Laboratories, Lenoir, NC, CBER's Office of Enforcement found numerous significant violations relating to the company's GMP compliance in manufacturing its allergenic extracts. Violations cited...

Merck lacking in GMPs for production of asparaginase intermediate, according to July warning letter.
August 1, 2005... A July 22 warning letter was issued to Merck and Co., Whitehouse Station, NJ, because FDA found conditions that did not meet with GMPs in the production of asparaginase intermediate in the firm's Riverside, PA, plant. Deviations found in...

American Medical fails to validate processes; CAPAs and MDRs also cited.(Medical devices)
August 1, 2005... A May 4-6 inspection of American Medical Specialties, Largo, FL, which manufactures sterile and non-sterile bone screws, revealed the firm was not in conformance with the QS Regulation, netting the firm a July 18 warning letter. Among the...

Non-conforming product recurrence nets letter for Arrow International.
August 1, 2005... A March 31-April 11 inspection of Arrow International, Reading, PA, uncovered QS Regulation violations for the firm's Percutaneous Thrombolytic Catheters. Arrow was cited in the June 3 warning letter for failure to identify the actions...

Lydall/Charter receives letter for validation flaws.
August 1, 2005... GMP and QS deficiencies were uncovered during a Jan. 6 and Jan. 25 inspection of Charter Medical, Winston-Salem, NC, which uses blood administration sets, plasma/fluid transfer sets/blood transfer bags and neonatal/pediatric aliquot systems...

Medical Science fails to implement CAPAs, document complaints.
August 1, 2005... A July 7 warning letter was issued to Medical Science Products, Canal Fulton, OH, stemming from a June 7-10 FDA inspection that uncovered quality system violations involving controls used for manufacturing, packing, storing and installing the...

Superior Rehab comes up short on QS rules.
August 1, 2005... Significant quality system regulations violations were uncovered by FDA's Dallas District during a May 9 and 25 inspection of Superior Rehab Technology, San Antonio. The firm manufactures and distributes electronic muscle stimulators for...