483 and warning letter issued for unapproved, misbranded
drug.(Human Drugs)
Anderson Pharmaceuticals, Norwich, NY, New York District, Buffalo
Office
FDA discovered numerous deficiencies during a recent inspection of
Anderson Pharmaceuticals, which resulted in an . . .
Audits focusing on computers that don't generate accurate
adverse event reports: FDAer urges firms to report problems before
age
WASHINGTON -- FDA field investigators have discovered some
manufacturers relying on computer systems that may not abide by the
rules when it comes to compiling adverse experience data.
Addressing . . .
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, . . .
FDA cites tissue bank for incomplete donor records.(Blood &
Biologics)
St. Luke's Hospital, Maumee, OH, Cincinnati District
Registered hospital tissue bank donor center St. Luke's
Hospital netted a three-item 483 for shoddy documentation records.
For example, the . . .
American Sunlight slapped with 483, warning letter.(Medical
Devices)
American Sunlight, Inc., Huntington Beach, CA, Los Angeles District
American Sunlight, a onetime mechanical and powered wheelchair
manufacturer based in Hunting-ton Beach, CA, received a . . .
Czech device maker cited for validation process and quality
problems.(Medical Devices)
Gel-Med International, Kamanne Zehrovice, Czech Republic, Center
for Devices
FDA discovered numerous serious deficiencies at Gel-Med's
Czech Republic plant, which landed the firm a six-item 483 . . .
FDA slaps drug maker with 12-item 483 for sweeping
violations.(Human Drugs)
Person & Covey, Glendale, CA, Los Angeles District
Prescription and OTC drug manufacturer Person & Covey netted a
12-item 483 for widespread GMP deficiencies that included lack of both
process . . .
Topical drug maker cited for 'wide-ranging
deficiencies'.(Human Drugs)
Island Kinetics, Inc., Tempe, AZ, Irvine District
Island Kinetics, Tempe, AZ, received a three-item 483 for quality
system, production system, and laboratory system violations, including
failure . . .
Serious and numerous GMP deficiencies land Indian firm 26-item
483.(Human Drugs)
Granules India, Ltd., Jeedimetla Hyderabad, India, Center for Drugs
Significant GMP deficiencies, including shipping product to the
U.S. before initiating process validation studies, landed . . .
Lyophilized products appear to be under FDA microscope.
PHILADELPHIA -- FDA inspectors appear to be paying closer attention
to lyophilization in pharmaceutical plants, an expert said here May 13.
"We're seeing a lot of development in the area . . .
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, . . .
Cytogen slapped with 11-item 483 for numerous quality
deviations.(Blood & Biologics)
Cytogen Corp., Princeton, NJ, CBER Team Biologics
A Team Biologics inspection of biopharmaceutical manufacturer,
Cytogen Corp., uncovered numerous and substantial deviations, which
included . . .
Adventist Health Walla Walla General Hospital shows complete
recovery.(Blood & Biologics)
Adventist Health Walla Walla General Hospital, Walla Walla, WA,
Seattle District
Registered hospital blood bank and autologous donor center
Adventist Health Wall Walla General Hospital passed an . . .
Janssen's Belgium device plant comes up short on validation,
testing.(Medical Devices)
Janssen Pharmaceutica, Beerse, Belgium, Center for Devices
FDA discovered numerous serious deficiencies in Janssen's
Belgium plant, which landed the firm an eight-item 483 following the
October . . .
West Ward lands 483 for investigation deficiencies.(Human/Animal
Drugs)
West Ward Pharmaceutical, Eatontown, NJ, New Jersey District
Tablet and capsule manufacturer West Ward Pharmaceuticals received
a three-item 483 for invalidated investigations, annual product . . .
Nanjing cited for inadequate testing, failure to follow
SOPs.(Human/Animal Drugs)
Nanjing Pharmaceutical Factory, Nanjing, China, Center for
Veterinary Medicine
Foreign human and veterinary bulk API manufacturer Nanjing
Pharmaceutical received a two-item 483 for inadequate . . .
Supplement distributor escapes 483 but gets warning letter for
misbranding.(Human/Animal Drugs)
American Nutraceutical, Atlanta, GA, Atlanta District
Although American Nutraceuticals managed to avoid a 483 following
its initial inspection in July 2003, it received a warning letter from
FDA . . .
FDA beefs up criminal enforcement with help from states'
attorneys.
WASHINGTON -- FDA-regulated firms might long for the days when they
worried about misdemeanor liability, when most criminal investigations
were conducted by lawyers in FDA's Office of Consumer . . .
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, . . .
Tissue bank donor records inadequate; nets 1-item 483.(Blood
& Biologics)
Southeast Tissue Alliance, Inc., Gainesville, FL, Florida District
FDA cited the Southeast Tissue Alliance in a one-item 483 for
failure to follow written procedures in obtaining, reviewing, . . .
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