4-item 483 to contract lab for poor quality control, lack of test
procedures.(CROs)
Celsis Laboratory Group, St. Louis, Lenexa, KS, District
Because of a quality control unit that lacked authority to
investigate errors, and no established test procedures, Celsis
Laboratory . . .
Utah Medical Products slapped with two 483s in consecutive years;
firm sues agency.(MEDICAL DEVICES)
Utah Medical Products, Midvale, UT, Denver, CO, District
Utah Medical Products (UTMD), Midvale, UT, in recent audits was hit
with two 483s that cited numerous quality systems problems. In . . .
Repackager slapped with 10-item 483 for no design and development
plan.(MEDICAL DEVICES)
CareFore Medical Incorporated, Olathe, KS, Lenexa, KS, District
CareFore Medical Incorporate, Olathe, KS, was the recipient of a
10-item 483 because of the lack of establishment of a proper . . .
5-item 483 to drug manufacturer for lack of control procedures
and for contamination issues.(HUMAN DRUGS)
Bioniche, Teo, County Galway, Ireland, CDER
Bioniche, Teo, County Galway, Ireland, received a five-item 483 due
to lack of control procedures to validate the performance of
manufacturing . . .
SOCMA and EFCG call for level playing field for domestic and
foreign API manufacturers.
Increased regulatory oversight of international pharmaceutical
firms, particularly those based in India and China, is essential to
increase patient safety and regional/national security, according . . .
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 releases SFBC 483s, citing case histories, inadequate
investigations and protocol violations.(MEDICAL DEVICES/ CROs)
South Florida Bioavailability Clinical International (SFBC), Miami,
FL, Maitland, FL, District
South Florida Bioavailability Clinical International (SFBC),
headquartered in Miami, FL, was cited . . .
Device manufacturer slapped with 9-item 483 for failure to report
corrective/removal actions.(MEDICAL DEVICES/ CROs)
OrthoHelix Surgical Designs, Akron, OH, Cincinnati, OH, District
OrthoHelix Surgical Designs, Akron, OH, was the recipient of a
nine-item 483s that cited failure to report corrective or . . .
EM innovations nets 8-item 483 for CAPAs, lack of quality
audits.(MEDICAL DEVICES/ CROs)
EM Innovations, Galloway, OH, Cincinnati, OH, District
Lack of corrective and preventive actions (CAPAs) and quality
audits resulted in an eight-item 483 in a 2006 inspection for the . . .
Luitpold Pharma cited for inadequate validation of sterilization
processes.(HUMAN DRUGS)
Luitpold Pharmaceuticals, Shirley, NY, Jamaica, NY, District Office
Procedures designed by Luitpold Pharmaceuticals, Shirley, NY, to
prevent microbiological contamination of drug products did not . . .
FDAer characterizes industry as lagging behind quality systems
initiatives.
PHILADELPHIA -- Noting that process analytical technology (PAT)
"is now clearly a component of the quality by design principles the
agency is looking for from industry," FDA's Philadelphia
District . . .
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, . . .
Inadequate quality policy nets 9-item 483 for B. Braun
Med.(MEDICAL DEVICES)
B. Braun Med, Cherry Hill, NJ, Parsippany, NJ, District
Poor implementation by management of an effective quality policy
led to the issuance of a nine-item 483 for B. Braun Med, Cherry Hill,
NJ. . . .
Plantex clears audit; questions arise about contract lab
supervision.(HUMAN DRUGS)
Plantex Ltd. Chemical Industries, Nentanya, Israel, Center for
Drugs
A preapproval and GMP inspection of the active pharmaceutical
ingredient (API) manufacturer Plantex Ltd. Chemical . . .
K. C. Pharma slapped with whopping 45-item 483 citing numerous
sterility issues.(HUMAN DRUGS)
K.C. Pharmaceuticals, Pomona, CA, Irvine, CA, District
K.C. Pharmaceuticals, located in Pomona, CA, received a big 45-item
483 that cited many sterility and validation problems, according to . . .
Office of Compliance putting QbD into practice; incentive for
industry is 'regulatory relief'.
PHILADELPHIA -- In a broad-stroke presentation that touched on how
new guidances and initiatives are being applied by CDER's Office of
Compliance, Mr. Kristen Evans, senior regulatory operations . . .
Batch review/failure investigations top 483 cites for drugs in FY
'06.
PHILIDELPHIA -- The top GMP compliance deviation for FY 2006 was
batch review/failure investigations, which were cited in 16.3% of the
818 observations, a senior Office of Compliance officer stated . . .
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, . . .
Device manufacturer comes up short on quality system, plans and
audits.(MEDICAL DEVICES)
Restorative Health Services, Nashville, TN, New Orleans, LA,
District
Failure to establish an appropriate quality system, quality plan
and procedures for conducting quality audits netted a . . .
RA Medical hit with 6-item 483 for unfilled product report,
faulty design plans.(MEDICAL DEVICES)
RA Medical Systems, Carlsbad, CA, Irvine, CA, District
RA Medical Systems, Carlsbad, CA, received a six-item 483 in a 2005
initial inspection because it failed to file several product reports . . .
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