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, . . .
EIR denials.
The following is a list of EIRs that FDA has declined to release
under the Freedom of In-formation Act because, in the agency's
words, they "constitute a record compiled for law . . .
3 483s for CBL focus on aseptic processing, media fills,
sterility procedures.(BLOOD & BIOLOGICS)
Chesapeake Biological Laboratories, Baltimore, MD, Baltimore
District/CBER
Three recent 483s for biologic and sterile drug contract
manufacturer Chesapeake Biological Laboratories (CBL), . . .
DMRs, CAPAs and MDRs highlight 14-item 483 for Ram
Precision.(MEDICAL DEVICES)
Ram Precision Industries, Centerville, OH, Cincinnati District
Ram Precision Industries, Centerville, OH, a manufacturer of
stainless steel parts for various medical devices, was slapped with . . .
9-item 483 given to drug firm for lab test flaws, cleaning
records.(HUMAN DRUGS)
Diversified Manufacturing Corp., Newport, MN, Minneapolis District
Diversified Manufacturing Corp., Newport, MN, was slapped with a
nine-item 483 because drug products required to be free of . . .
Boehringer nets 12-item 483 citing control procedures and batch
failure reviews.(HUMAN DRUGS)
Boehringer Ingelheim Vetmedica, Elwood, KS, Lenexa, KS, District
Lack of control procedures to validate process performance and
inadequate review of batch failures led to a 12-item 483 for . . .
Final guidance for GMP inspection dispute resolution does not
cover PAIs.
FDA Jan. 11 released its final guidance titled "Guidance for
Industry: Formal Dispute Resolution: Scientific and Technical Issues
Related to Pharmaceutical CGMP," which does not apply . . .
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 . . .
Lab cited in 1-item 483 for failing to establish specs,
standards, test procedures.(BLOOD & BIOLOGICS)
Research & Diagnostic Laboratories, Knoxville, TN, New Orleans
District
Failure to establish scientifically sound and appropriate
specifications, standards and test procedures to assure that . . .
Two inspections for blood bank net clean report, 1-item
483.(BLOOD & BIOLOGICS)
Blood Bank of San Bernardino and Riverside Counties, San
Bernardino, CA, Irvine, CA, District
The Blood Bank of San Bernardino and Riverside Counties, San
Bernardino, CA, was not cited for any . . .
Incomplete quality audits, non-conforming product procedures and
Part 11 noted for Guidant.(MEDICAL DEVICES)
Guidant Corp., St. Paul, MN, Minneapolis District
A recent inspection of Guidant, St. Paul, MN, found the device
manufacturer did not have complete quality audit procedures, nor had all
actions . . .
Lack of Part 11 compliance cited in 7-item 483 for Takeda
Chemical.(HUMAN DRUGS)
Takeda Chemical Industries, Hikari, Yamaguchi, Japan, CDER
Computerized and paper systems used in the recording of quality
control testing data failed to meet the requirements of 21 CFR Part . . .
Schering-Plough faulted in 6-item 483 for irregular water system
maintenance.(HUMAN DRUGS)
Schering-Plough HealthCare Products, Cleveland, TN, New Orleans
District
Schering-Plough HealthCare Products, Cleveland, TN, received a
six-item 483 because records showed that sanitization and . . .
Avid Bioservices advised to follow GMPs for clinical trial drugs,
but cleared to produce APIs for Hylenex.(HUMAN DRUGS)
Avid Bioservices, Tustin, CA, Irvine, CA, District
A 483 was not issued in a recent GMP establishment inspection to
Avid Bioservices, a mammalian cell culture contract manufacturing
facility in . . .
Cell cultures, elastomers, GMP failures are common 483 items with
disposables.
RESTON, VA -- Some of the most common 483 observations in the use
of PVC disposable medical devices in the production of
biopharmaceuticals fall into three general areas: cell cultures,
elastomers . . .
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, which . . .
Biogen slapped with 12-item 483 for inadequate complaint
procedures, Part 11 issues.(Blood & Biologics)
Biogen Idec, Inc., Research Triangle Park, NC, Center for Biologics
For complaint procedures not assuring full investigation and an
inadequate deviation reporting system that, among other flaws, . . .
Repacker/labeler served with 483 for QA system flaws, design
control, MDR procedures: inspection "a complete surprise" to
Tenaco
Tenacore Holdings, Santa Ana, CA, Irvine District
Tenacore Holdings, Santa Ana, CA, received a 10-item 483 for an
inadequate QA system, improper design controls and a lack of written MDR
[Medical . . .
API manufacturer avoids 483, lack of process and cleaning
validation cited.(Human Drugs)
Westwood Chemical Corporation, Middletown, NY, Jamaica, NY,
District
Westwood Chemical Corporation, Middletown, NY, a manufacturer of
APIs, avoided a 483, but several deviations from GMPs were . . .
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