Medical image printer manufacturer cited for quality, CAPA
issues.(Medical Devices)
Codonics, Middleburg Heights, OH, Cincinnati District
FDA discovered numerous serious deficiencies in Codonics'
corrective and preventative actions (CAPA) system, its management and
design . . .
Searle lands 10-item 483 for shoddy stability, validation
studies.(Human Drugs)
Searle Ltd., Barceloneta, Puerto Rico, San Juan District
FDA discovered inadequate stability studies and validation
Searle's manufacturing processes for several drugs during a GMP
inspection of . . .
Nerve gas antidote manufacturer nets 483 for aseptic
deficiencies.(Human Drugs)
Meridian Medical Technologies, St. Louis, MO, Kansas City District
A pre-approval inspection for Meridian Medical Technologies'
ANDA for Diazepan 5mg/ml auto injector found the firm . . .
AAI escapes 483 despite lack of validation data, testing
deficiencies.(Human Drugs)
AAI International, Charleston, SC, Atlanta District
Although AAI International lacked approved assay specification and
validation data, it managed to elude a 483 from FDA following a July
2003 . . .
McClellan stands firm on reimportation, despite threat to his CMS
nomination: seeks foods-like authority for Rx drug imports.
WASHINGTON -- FDA Commissioner Mark McClellan, M.D., said Feb. 26
that FDA will not relax its stance to allow wider reimportation of
lower-cost, non-U.S. sourced prescription medications, unless . . .
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, . . .
Blood bank nets 8-item 483 for quality control failures.(Blood
& Biologics)
Mississippi Blood Services, Jackson, MS, New Orleans District
Serious lapses in quality control and documentation landed
Mississippi Blood Services an eight-item 483, for which the firm
received . . .
QS deficiencies, use of cat for rodent control lands IVD exporter
483, warning.(Medical Devices)
Eagle Diagnostics, Cedar Hill, TX, Dallas District
If FDA were a cat, it snared both an "Eagle" and a mouse
during a recent inspection of an in vitro diagnostics repacker and
relabeler.
FDA's . . .
Austrian firm lands 483 for testing, validation
deficiencies.
Biochemie GmbH, Kundl, Austria, CDER
While FDA found Biochemie GmbH to be in substantial compliance with
GMPs, the firm received a four-item 483 for testing and validation
deficiencies following . . .
Barr Labs gets clean report from FDA for former Duramed
facility.
Barr Laboratories, Cincinnati, OH, Cincinnati District
Barr Laboratories got clearance from FDA for removing from its
label the claim that "effectiveness in long-term therapy treatment
for . . .
Alpharma gets blasted with 59-item 483 citing quality system
failures.(Human Drugs)
Alpharma USHP, Baltimore, MD, Baltimore District
Serious quality deficiencies for a number of products landed
human-drug maker Alpharma USHP a whopping 59-item, 24-page 483.
Deficiencies . . .
Pharmaceutical Inspectorate will follow 'team
biologics' model, create PAT team: Web-based investigator training
offered.
WASHINGTON -- "Team Biologics" brought a new inspection
model to FDA, which included more specialized training and additional
inspection guidance materials, including written SOPs for the team.
. . .
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, . . .
Haemachem cited for failure to ensure sterility, manufacturing
records.(Blood & Biologics)
Haemachem Division, Wako Chemicals, St. Louis, MO, CBER
A "Team Biologics" inspection conducted by FDAer Ralph
Erickson of FDA's Office of Regulatory Affairs and CBER's Core
Team, found that . . .
Steris cited for failing to report a correction/removal to
FDA.(Medical Devices)
Steris Corp., Mentor, OH, Cincinnati District
FDA cited Steris Corp. in an eight-item 483 for failing to report a
correction/removal to FDA and not justifying in writing why a field
notification . . .
OTC manufacturer cited for OOS results, quality failures.(Human
Drugs)
Pharmaceutical Formulations Inc., Edison, NJ, North Brunswick
Resident Post, NJ District
OOS results, validation deficiencies and failure to investigate
were among quality system deficiencies . . .
Cumberland Swan recovers nicely from previous 30-item 483.(Human
Drugs)
Cumberland Swan, Smyrna, TN, New Orleans District
OTC pharmaceutical manufacturer Cumberland Swan escaped a 483 from
FDA's New Orleans District following an audit last year.
Investigators . . .
Inspections, seizures, injunctions rise in '03, recalls,
warnings drop: not following production SOPs No. 1.
ATHENS, GA -- The Centers for Drugs and Biologics each completed
more inspections in fiscal 2003 and issued more 483s, but while warning
letters and recalls dropped from fiscal 2002, seizures and . . .
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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