Firm hit with two consecutive 483s for SOP failures, inadequate
procedure for HPLC.(Human Drugs)
Pharmaceutical Manufacturing Research Services, Horsham, PA,
Philadelphia District
Pharmaceutical Manufacturing Research Services, Horsham, PA, was
slapped with two 483s in a row for not . . .
Fontarome Chemical passes inspection, but flaws in packing and
cleaning validation noted.(Human Drugs)
Fontarome Chemical, St. Francis, WI, Minneapolis District
Fontarome Chemical, St. Francis, WI, received a clean report and no
483 was issued following a recent FDA audit.
However, the firm did . . .
Chemistry reviewers seen joining in on GMP inspections; setting
tighter specs a goal.
Center for Drugs staffers who review the chemistry, manufacturing
and controls (CMC) sections of NDAs and ANDAs may soon be joining field
investigators on GMP audits, Office of New Drug Chemistry . . .
Inspection log.
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 . . .
8-item 483 issued to blood bank for blood storage and equipment
failures.(Biologics)
Community Blood Center of Greater Kansas City, Kansas City, MO,
Lenexa, KS District
Failure to store blood at a proper temperature and multiple
equipment failures in violation of blood GMPs (21 . . .
Blood center receives 483s at separate facilities for failures in
SOPs and not following procedures.(Biologics)
Blood Center of Iowa, Marshalltown, IA, Lenexa, KS District
The Blood Center of Iowa, which has facilities in Des Moines and
Marshalltown, IA, received a two-item 483 at both locations because . . .
23-item 483 to Biomerieux cites MDR, QA, CAPA, and validation
failures.(Medical Devices)
Biomerieux, Durham, NC, Atlanta District
Biomerieux, Durham, NC, was handed a 23-item 483 for Medical Device
Reports (MDRs) not being submitted to FDA within 30 days, not
implementing an . . .
PFAB Lp fails to clean equipment and test adequate batches of
drug product in 10-item 483.
PFAB Lp (PharmaFab), Grand Prairie, TX, Dallas District
PFAB Lp (PharmaFab), Grand Prairie, TX, failed to properly clean
and maintain equipment and utensils, and also did not test an . . .
CRC receives 3-item 483 for ADE flaws; Repligen files injunction
to continue to market porcine secretin.(Human Drugs)
ChiRhoClin, Burtonsville, MD, Balimore District
ChiRhoClin (CRC), Burtonsville, MD, was hit with a three-item 483
and a subsequent warning letter because "written procedures have
not been . . .
FDA envisions slight drop in audits for biologics, drugs in FY
'06; device inspections to stay even.
An analysis of FDA's fiscal year 2006 budget request indicates
the agency is increasing funding to improve the safety of marketed drug,
while decreasing the total number of inspections in most . . .
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, . . .
Audit of NIH blood bank nets 6-item 483, but no 483 issued in
subsequent inspection.(Biologics)
NIH/Warren Grant Magnuson Clinical Center, Bethesda, MD, Baltimore
District
Investigation and reporting violations were noted in an initial
inspection of NIH/Warren Grant Magnuson Clinical . . .
Baltimore blood bank cited in 5-item 483 for Part 11 flaws,
inadequate process control procedures.(Biologics)
Mercy Medical Center, Baltimore, MD, Baltimore District
The blood bank at Mercy Medical Center, Baltimore, MD, received a
five-item 483 for 21 CFR Part 11 failures, including not checking . . .
Tyco Healthcare/Kendall hit with 3-item 483 for failure to follow
validation procedures.(Medical Devices)
Tyco Healthcare/Kendall, Argyle NY, Jamaica District
A three-item 483 cited Tyco Health-care/Kendall, Argyle, NY, for
not following procedures for the validation or verification of design
changes . . .
O'Farrell hit with 13-item 483 for deviations in quality,
lab controls; owner lashes out at FDA.(Human Drugs)
Wallace O'Farrell, Puyallup, WA, Seattle District
Wallace O'Farrell, Puyallup, WA, received a 13-item 483 and a
subsequent warning letter for failures in quality and laboratory control
systems, . . .
API repackager nets 11-item 483 for inadequate sanitation, lack
of environmental controls.(Human Drugs)
Integra Chemical Company, Renton, WA, Seattle District
A second inspection of Integra Chemical Company, Renton, WA,
resulted in an 11-item 483, finding several previous observations were
not . . .
Talk to FDA before moving into PAT, FDAer advises.
WASHINGTON -- Companies should speak to FDA before lurching into
PAT, but should first--even before consulting with FDA--determine
internally where PAT will lead to the most benefit, according to . . .
Rapid methods for bioburden/sterility, plus Team Biologics impact
among 2005 initiatives at CBER.
WASHINGTON -- FDA's Center for Biologics is focusing on a
number of quality initiatives in 2005, notably developing rapid methods
for bioburden detection and evaluating "Team Biologics" audits
on . . .
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, . . .
D.C. blood bank gets 5-item 483 for documentation failures, not
following SOPs.(Blood & Biologics)
Howard University Hospital Blood Bank, Washington, D.C., Baltimore
District
Howard University Blood Bank in Washing-ton, D.C. received a 5-item
483 for failing to perform thorough investigations, . . .
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