Device manufacturer cited for CAPAs and MDRs in 11-item
483.(MEDICAL DEVICES)
Advanced Imaging Research, Cleveland, OH, Cincinnati, OH, District
Advanced Imaging Research, Cleveland, OH, was the recipient of an
11-item 483 in a 2006 inspection due to improper CAPA . . .
Vi Jon Labs gets two 483s for written procedures, improper
calibration.(HUMAN DRUGS)
Vi Jon Laboratories, St. Louis, MO, Lenexa, KS, District
Two FDA inspections of Vi Jon Laboratories, St. Louis, MO, revealed
a lack of written procedures for production and process controls, . . .
Kutol Products receives 4-item write-up for failure to reject
non-conforming batches.(HUMAN DRUGS)
Kutol Products, Cincinnati, OH, Cincinnati District
Kutol Products, Cincinnati, OH, was hit with a four-item 483 for
failure to reject batches of hand sanitizer that did not meet . . .
FDA's new CMC review process aims to foster more efficient,
science-based control of product quality.
PHILADELPHIA -- FDA's new systems-based approach to chemistry,
manufacturing and control (CMC) review promises to be one in which
companies that demonstrate adequate process knowledge and control . . .
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, . . .
BioLife Plasma cleared of wrongdoing in donor fatality involving
42 year-old male.(BIOLOGICS)
BioLife Plasma Services, Ruston, LA, Center for Biologics
A CBER-directed inspection was conducted on BioLife Plasma
Services, Ruston, LA, because of a donor fatality that occurred on Dec.
9, . . .
Pharmaceutical Specialties passes FDA audit; Part 11 mentioned in
EIR.(HUMAN DRUGS)
Pharmaceutical Specialties, Rochester, MN, Minneapolis District
No 483 was issued in an inspection of Pharmaceutical Specialties,
Rochester, MN. However, several observations were noted regarding . . .
Cassidy slapped with 7-item 483 in 1st inspection; 1-item 483 in
2nd.(HUMAN DRUGS)
Cassidy, St. Paul, MN, Minneapolis District
St. Paul, MN-based cosmetic manufacturer Cassidy received a
seven-item 483 for lack of stability testing and employee training,
among other violations. . . .
Cosmetics manufacturer cited for packaging issues and unsanitary
practices.(HUMAN DRUGS)
Aveda, Minneapolis, Minneapolis District
A 483 was not issued following an FDA audit of cosmetics
manufacturer Aveda in Minneapolis, but the agency noted the firm
produced a breath freshener that . . .
Ameri-Pac written up by agency for contaminated equipment and
lack of cleaning records.(HUMAN DRUGS)
Ameri-Pac, St. Joseph, MO, Lenexa, KS, District
Ameri-Pac, an animal nutritional supplement manufacturer based in
Saint Joseph, MO, received an 11-item 483 because its equipment and
utensils were . . .
9-item 483 to Alwyn for lack of validation procedures and poor
laboratory controls.(HUMAN DRUGS)
Alwyn, Lake Crystal, MN, Minneapolis District
Alwyn, an OTC drugs and cosmetics manufacturer in Lake Crystal, MN,
was hit with a nine-item 483 because control procedures were not
established that . . .
FDA moving ahead with TSE rule, despite 'theoretical'
risk from blood, plasma products.
Despite noting there is just a "theoretical risk" from
blood and plasma products, FDA can be expected within the year to issue
proposed rules regarding minimizing the risk of new variant . . .
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 Infor-mation (FOI) Log, . . .
Device firm passes audit; more documentation needed on
complaints.(MEDICAL DEVICES)
American Medical Systems, Minnetonka, MN, Minneapolis District
American Medical Systems (AMS), Minnetonka, MN, was not cited in a
recent QSIT inspection by investigator Jocelyn Muggli from . . .
Tyco receives clean report from agency.(HUMAN DRUGS)
Tyco Healthcare, St. Louis, MO, Kansas City District
A recent GMP inspection covering the manufacturing operations of
methylphenidate hydrochloride USP, produced by Tyco Healthcare, St.
Louis, . . .
I Shay passes inspection with no observations noted.(HUMAN
DRUGS)
I Shay Cosmetics, Hawthorne, CA, Irvine, CA, District
No 483 observations were noted in an initial inspection of I Shay
Cosmetics, Hawthorne, CA, but investigator John Gonzalez from the
Irvine, . . .
Classic Cosmetics cited for lack of process and cleaning
validation in 4-item 483.(HUMAN DRUGS)
Classic Cosmetics, Chatsworth, CA, Irvine, CA, District
Classic Cosmetics, Chatsworth, CA, a contract manufacturer of
cosmetics and OTC drug products, received a four-item 483 for lack of
process . . .
Cima Labs receives 3-item 483, but gets okay in follow-up
inspection.(HUMAN DRUGS)
Cima Laboratories, Brooklyn Park, MN, Minneapolis District
An inspection of Cima Laboratories, Brooklyn Park, MN, netted the
prescription and OTC drug manufacturer a three-item 483 for . . .
Central Admixture slapped with 2-item 483 cited for faulty
microbiological tests.(HUMAN DRUGS)
Central Admixture Pharmacy Services, Santa Fe Springs, CA, San
Diego, Irvine, CA, District
An unannounced GMP inspection of Central Admixture Pharmacy
Services, Santa Fe Springs, CA, revealed . . .
SOPs on production, process controls top 483 citations for drugs
in '05.
ATHENS, GA -- "Written production and process control
procedures not followed" was the No. 1 violation cited on 483s
issued to drug manufacturers in fiscal 2005, followed by other SOP
issues.
. . .
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