18-item Bausch & Lomb 483 leaves uncertain if MoistureLoc use
led to Fusarium infections.(DRUGS/MEDICAL DEVICES)
Bausch & Lomb, Greenville, SC, Atlanta District
FDA May 16 released an 18-item 483 at the conclusion of its
seven-week inspection of Bausch & Lomb's Greenville, SC, plant
where the firm . . .
API manufacturer clears FDA inspection.(DRUGS/MEDICAL
DEVICES)
American Peptide Company, Vista, CA, Irvine, CA District
A routine GMP establishment inspection of American Peptide, Vista,
CA, resulted in no 483 being issued. Conducting the audit . . .
Direct Final Rule on GMPs for Phase I INDs withdrawn due to
strong industry response.
FDA May 11 withdrew its Direct Final Rule (DFR) "Approaches to
Complying with GMPs During Phase I INDs," because of
"substantive and/or adverse comments" that were received after
the rule was . . .
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, . . .
Guidant receives 1-item 483 for quality problem
procedures.(MEDICAL DEVICES)
Guidant, St. Paul, MN, Minneapolis District
Guidant, St. Paul, MN, was cited in a one-item 483 inspection
conducted recently because not all of the actions needed to correct and
prevent the . . .
Yamanouchi receives 6-item 483 for OOS; clean report on 2nd
inspection.(HUMAN DRUGS)
Yamnouchi Pharmaceutical, Takahagi, Ibaraki, Japan, CDER
A lack of corrective actions in response to OOS results netted a
six-item 483 for Yamnouchi Pharmaceutical in Takahagi, Ibaraki, . . .
Taro slapped with 24-item 483, citing cleaning validation and
verification testing practices.(HUMAN DRUGS)
Taro Pharmaceutical Industries, Haifa Bay, Israel. CDER
Questionable cleaning validation and verification testing practices
highlighted a 24-item 483 for Taro Pharmaceutical Industries, based . . .
Three recent inspections result in 483s for Crown
Laboratories.(HUMAN DRUGS)
Crown Laboratories, Johnson City, TN, New Orleans District
A 483 resulted from each of three recent inspections for Crown
Laboratories, a manufacturer of human OTC and prescription drug . . .
Drug inspections up 3% from FY '04, but overall FDA audits
drop 9% in '05.
FDA increased its inspections of pharmaceutical manufacturers by 3%
in fiscal 2005, and a whopping 14.7% for veterinary products, but
overall audits by the agency dropped 9% from fiscal 2004, . . .
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 SOPs and donor records net 5-item 483 for plasma
center.(BLOOD/BIOLOGICS)
International BioResources, Milwaukee, WI, received a five-item 483
for a lack of records of unsuitable donors, and for failure to maintain
and follow SOPs for the collection and processing of . . .
GenTrac tripped up by flaws in sterility failure
investigations.(BLOOD/BIOLOGICS)
GenTrac, a licensed plasma derivative manufacturer located in
Middleton, WI, was slapped with a five-item 483 for failure to follow
its own SOP for sterility failure and media fill growth, . . .
Greer Labs slapped with 16-item 483 for questionable expiration
dates, lab controls.(HUMAN DRUGS)
Greer Laboratories, Lenoir, NC, received a 16-item 483 following a
recent GMP inspection for improper expiration dates on drug products,
and for laboratory controls that did not include the . . .
CAPA and QC flaws net 2-item 483 for Cambridge Major Jabs.(HUMAN
DRUGS)
A recent inspection of Cambridge Major Laboratories, Germantown,
WI, revealed that the contract lab failed to implement corrective
actions in the production of active pharmaceutical ingredients . . .
Ben Venue Labs ducks 483, two minor training issues noted.(HUMAN
DRUGS)
Ben Venue Laboratories, Bedford, OH, did not receive a 483 in a
2006 GMP inspection, but FDAers on the case noted minor deficiencies
regarding employee training, and a rushed review of three . . .
Data in EudraGMP should be current, concern over high level of
detail in GMP Guide Annex XIV.
LONDON -- Several associations representing the pharmaceutical
industry expressed concern at a recent European Medicines Agency (EMEA)
GMP inspection update here regarding the level of details in . . .
Final QS guidance seeks periodic auditing of suppliers/contactors
based on risk, not sole reliance on COAs; quality unit.
FDA's final guidance, "Quality Systems Approach to
Pharmaceutical CGMP Regulations," calls for both auditing of
suppliers and contractors as well as analysis of their certificates of
analysis . . .
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, . . .
Theken Spine slapped with 4-item 483 for improper investigations,
CAPAs.(MEDICAL DEVICES)
Theken Spine LLC, Akron, OH, Cincinnati, OH, District
A lack of investigation of non-conforming product and
non-documentation of CAPAs netted a four-item 483 for Theken Spine LLC,
Akron, OH, in a . . .
Shelhigh gets 12-item 483 for risk analysis, lack of control of
design process.(MEDICAL DEVICES)
Shelhigh, Union, NJ, Parsippany, NJ, District
Incomplete risk analysis and failure to implement procedures to
control the design process of the medical device netted a 12-item 483
for Shelhigh, . . .
|
|