Foreign/domestic drug GMP inspections drop 106 from
'06.
Center for Drugs inspections dipped in FY2007 to 2,305 foreign and
domestic, compared to 2,411 in FY2006, according to new figures released
by the Office of Regulatory Affairs.
FDA's Center for . . .
Shelhigh agrees to consent order; halts device distribution until
GMP flaws are addressed.
Shelhigh, Union, NJ., agreed July 3 to stop distributing its
implantable medical devices until the company addresses all concerns
that FDA has with the firm's manufacturing processes . . .
Inspection log.
The following is a partial list of inspection documents that have
been requested under the Freedom of Information Act by various parties,
according to FDA's Freedom of Information (FOI) Log, . . .
Repeated complaint handling violation results in 6-item 483 for
MicroSurgical Tech.(MEDICAL DEVICES)
MicroSurgical Technologies, Redmond, WA, Bothell, WA, District
An uncorrected complaint-handing problem led to a six-item 483
being issued to MicroSurgical Technologies, Redmond, WA. Conducting . . .
Device manufacturer written up for validation process procedures
in 11-item 483.(MEDICAL DEVICES)
The Electrode Store, Buckley, WA, Bothell, WA, District
The Electrode Store, a medical device manufacturer in Buckley, WA,
was written up in an 11-item 483 because procedures were not . . .
API manufacturer cited for improper cleaning validation.(HUMAN
DRUGS)
Industriale Chimica, Sacronno, Italy, CDER
Industriale Chimica, Sacronno, Italy, received a two-item 483 due
to incomplete cleaning validation in the production of active
pharmaceutical . . .
Pre-approval GMP inspection nets biological lab 10-item
483.(HUMAN DRUGS)
Hollister-Stier Laboratories, Spokane, WA, CDER
Hollister-Stier Laboratories, Spokane, WA, was slapped with a
10-item 483 in a GMP pre-approval inspection for Biological Product
Deviation Reports . . .
Hi-Tech cited for contract labs' OOS results in 10-item
483.(HUMAN DRUGS)
Hi-Tech Pharmacal, Amityville, NY, Jamaica, NY, District
Hi-Tech Pharmacal, Amityville, NY, was hit with a 10-item 483 for a
number of violations regarding OOS at the firm's contract
laboratory, . . .
Health food firm cited for 23 GMP violations, company decries
"FDA raid on premises".(HUMAN DRUGS)
Alternative Health & Herbs Remedies, Albany, OR, Bothell, WA,
District
An herbal food manufacturer in Albany, OR, was written up for 23
GMP violations but claimed in strong terms in its written . . .
All FDA GMP inspections are systems-based as of 2006: industry
analyst.
As of 2006, all GMP inspections went to a systems-based model,
which includes quality, facilities and equipment, materials, production,
packaging and labeling, and laboratory systems, a senior . . .
Inspection log.(MEDICAL DEVICES)
The following is a partial list of inspection documents that have
been requested under the Freedom of Information Act by various parties,
according to FDA's Freedom of Information (FOI) Log, . . .
CAPAs and record keeping trip up Talon Acrylics in 3-item
483.(MEDICAL DEVICES)
Talon Acrylics, Portland, OR, Bothell, WA, District
Talon Acrylics, Portland, OR, a manufacturer of liquid
thermoplastic products for the dental industry, was written up in a
three-item 483 for . . .
Positron slapped with 9-item 483 for poor quality audits,
obsolete documents, calibration.(MEDICAL DEVICES)
Positron Corporation, Houston, TX, Dallas, TX, District
Failing to conduct quality audits, maintaining documents that were
obsolete and failing to keep proper calibration documentation . . .
Alza Corporation clears audit; verbal observation made about
questionable integrity testing.(MEDICAL DEVICES)
Alza Corporation, Vacaville, CA, Irvine, CA, District
Medical device manufacturer Alza Corporation, Vacaville, CA,
cleared a 2006 quality system audit with no 483 being issued. Only one
verbal . . .
Draxis Pharma nets 3-item 483 for software validation, failure to
implement corrective actions.(HUMAN DRUGS)
Draxis Pharma, Kirkland, Quebec, Canada, CDER
A quality, production, laboratory and packaging systems inspection
of Draxis Pharma, Kirkland, Quebec, Canada, revealed three GMP
violations--failure . . .
API manufacturer slapped with 4-item write up for flawed change
control and lab test records.(HUMAN DRUGS)
Chemtura Corporation, Memphis, TN, Nashville, TN, District
API [active pharmaceutical ingredient] manufacturer Chemtura
Corporation, Memphis, TN, received a four-item 483 in a 2006 GMP
inspection . . .
CMC pilot program succeeding in integrating concepts of QbD:
Nasr.
BALTIMORE, MD -- All NDAs under the CMC pilot program received by
the agency since FDA rolled out the program in 2005 have contained some
elements of quality-by-design (QbD), such as, better . . .
FDA guidance on new OTC drug, supplement AE reporting law seen by
September, audits to follow.
WASHINGTON -- FDA by September will issue new guidance on how
makers of OTC drugs and dietary supplements will report adverse events
under the new Dietary Supplement and Nonprescription Drug . . .
Inspection log.
The following is a partial list of inspection documents that have
been requested under the Freedom of Information Act by various parties,
according to FDA's Freedom of Information (FOI) Log, . . .
483/EIR update.
The following is Inspection Monitor's tri-annual update of
483s, EIRs and other documents from our RECORD-RETRIEVE Document
Retrieval & Research Service. Many of these documents have been
offered . . .
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