Inspection Monitor

Browse past and current articles from this publication.

Biopharmaceutical firms push for harmonized audits to eliminate cost, duplication of effort.
ATLANTA -- Biopharmaceutical manufacturers are eager for harmonized audits to avoid duplication of effort and save costs, which for some firms can be as high as $400,000 a day to achieve compliance . . .

Hyaluron slapped with 14-item 483 for inadequate records, testing.(HUMAN DRUGS)
Hyaluron, Burlington, MA NE District FDA investigators Brenda King, Amber Wardwell and Anthony Warchut issued a 14-item 483 following their inspection of Hyaluron's drug manufacturing facility in . . .

Procedural issues yield 3-item 483 for Millennium.(HUMAN DRUGS)
Millennium Pharmaceuticals, Cambridge, MA New England District Procedures covering handling of complaints and adverse events were deficient because they did not adequately detail the flow of infor . . .

SmithKline nets a single observation for improper testing of incoming shipments.(HUMAN DRUGS)
SmithKline Beecham, Bristol, TN Nashville District An inspection of SmithKline Beecham's Bristol, TN, site, dedicated to the manufacturing of non-sterile penicillin products for human and veterina . . .

API repackager gets slammed with 10-item 483 for quality system flaws.(HUMAN DRUGS)
Hawkins, Inc., Minneapolis, MN Minneapolis District FDA investigator Melissa Michurski observed multiple quality system failures in her inspection of API repackager Hawkins, Inc. Of 155 APIs rep . . .

FDA notes only two observations in 3M inspection.(HUMAN DRUGS)
3M, Northridge, CA Los Angeles District An FDA inspection team issued a 483 with just two observations for 3M's facility for manufacture of prescription tablets, aerosols and transdermal patches. . . .

Cardiac Science Corp. faulted for lapses in validation, CAPA, design history.(MEDICAL DEVICES)
Cardiac Science Corporation, Deerfield, WI Minneapolis District FDA investigators Joseph Edwin and Aaron Dunbar found that Cardiac Science Corporation had not validated and approved a process whos . . .

Inspection finds multiple quality system failures at Neurotone Systems.(MEDICAL DEVICES)
Neurotone Systems, Garland, TX Dallas District Neurotone Systems, a manufacturer of cranial electrotherapy stimulators, netted a 13-item FDA 483 from investigators Charles Brown and Rebecca O'Brya . . .

Inspector cites Pharmaceutical Labs for laboratory control and quality system flaws.(CROs)
Pharmaceutical Laboratories and Consultants, Des Plaines, IL Chicago District Contract testing laboratory Pharmaceutical Laboratories and Consultants (PLC) received a 14-item 483 from FDA investig . . .

Novartis nets 15-item 483 for problems at German vaccine facility.(BIOLOGICS)
Novartis Vaccines and Diagnostics, Marburg, Germany CBER The FDA inspection team of Omotunde Osunsanmi, Mihaly Ligmond and Robin Levis surveyed operations at Novartis Vaccines and Diagnostics in M . . .

Inspection log.
The following is a partial list of inspection documents that have been requested from FDA under the Freedom of Information Act (FOIA) by various parties, according to FDA's Freedom of Information Lo . . .

Supplying flu drugs, developing vaccine pose challenges, present quandaries.(Food & Drug)
Even as FDA, in response to requests from the U.S. Centers for Disease Control, issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel diagnostic and the . . .

Senate proposes new powers, funds for FDA inspections of drug and device facilities.(Food & Drug)
A revived safety proposal in the U.S. Senate would give regulators new funding and authority to inspect plants that make prescription drugs and medical devices, Bloomberg reported April 23. Legisl . . .

First Priority slapped with 25-item 483 for GMP violations.(HUMAN AND ANIMAL DRUGS)
First Priority, Elgin, IL Chicago District Veterinary drug manufacturer First Priority had corrected some deviations observed in its 2004 inspection, but FDA investigator Susan Bruederle found a n . . .

No 483 issued in Genzyme follow-up inspection for ADEs.(HUMAN AND ANIMAL DRUGS)
Genzyme Corporation, Cambridge, MA New England District During their inspection conducted July 24-25, 2007, FDA investigators Debra Emerson and Megan Haggerty found that Genzyme Corporation had ma . . .

FDA finds Iowa College of Pharmacy made required corrections in its operations.(HUMAN AND ANIMAL DRUGS)
University of Iowa College of Pharmacy Pharmaceutical Service Division, Iowa City, IA Kansas City District FDA Investigator Brent Hall conducted an inspection of the University of Iowa College of . . .

CAPA flaws result in 4-item 483 for Abbott Diagnostics.(DEVICES)
Abbott Diagnostics International, Barceloneta, Puerto Rico, San Juan District Abbott Diagnostics International (ADI) was found out of conformance with GMP regulations in its complaint handling and . . .

TEFTEC commits to quality improvements after receiving 12-item 483.(DEVICES)
TEFTEC Corp., San Antonio, TX Dallas District The manufacturer of OmegaTrac and BetaTrac powered wheelchairs, TEFTEC was found out of compliance with regulations relating to complaint handling, CA . . .

FDA cites CSL for 14 violations in vaccine manufacturing operations.(BIOLOGICS)
CSL Biotherapies, Victoria, Australia CBER Influenza vaccine maker CSL Biotherapies was handed a 14-item 483 after an inspection May 5-15, 2008, by FDA investigators Omotunde Osunsanmi and Joan Ad . . .

Inspection log.
The following is a partial list of inspection documents that have been requested from FDA under the Freedom of Information Act (FOIA) by various parties, according to FDA's Freedom of Information Lo . . .

QC unit failures, not following production procedures top human drug GMP 483 citations in FY '09.
ATHENS, GA -- The top three drug GMP violations in fiscal 2009 involved failings in manufacturers' quality control units, failure to adhere to production procedures and validation, but laboratory co . . .

No 483 for Nephron after follow-up inspection.(HUMAN DRUGS)
Nephron Pharmaceuticals, Orlando, FL Florida District Following a 2007 inspection that yielded a 483 that required official actions and resulted in voluntary destruction of certain drug products, . . .

Pharmaceutics receives 5-item 483 for laboratory testing, control flaws.(HUMAN DRUGS)
Pharmaceutics International, Hunt Valley, MD Baltimore District FDA investigators Kenneth Nieves and Tara Gooen found several lapses in laboratory procedures during their inspection of contract dr . . .

Biolase faulted for complaint handling, quality procedures.(MEDICAL DEVICES)
Biolase Technology, Irvine, CA Los Angeles District Biolase, manufacturer of Class II dental lasers including the Waterlase MD, received a five-item 483 from FDA investigator James Fleckenstein af . . .

Chattem cited for reporting failures, CAPA issues.(MEDICAL DEVICES)
Chattem, Inc., Chattanooga, TN Nashville District Chattem failed to report labeling changes made to its Icy Hot Heat Therapy patches after receiving at least 168 complaints of burns, skin irritati . . .

Edge Biologicals still not in compliance on some issues noted in previous inspections.(MEDICAL DEVICES)
Edge Biologicals, Memphis, TN New Orleans District An inspection conducted Jan. 29-Feb. 2, 2007, found that Edge Biologicals had not yet corrected deficiencies in its conformity to GMPs identified . . .

Procedural lapses yield 9-item 483 for Lynn Medical Instruments.(MEDICAL DEVICES)
Lynn Medical Instrument Company, Wixom, MI Detroit District Due to its failure to establish a variety of quality procedures, Lynn Medical Instrument Co. received a nine-item 483 following an inspe . . .

Donor Referral Services cited for record-keeping gaps, procedural flaws.(BLOOD AND BIOLOGICS)
Donor Referral Services, Raleigh, NC Atlanta District Donor Referral Services, a human tissue recovery firm, was unable to supply FDA investigators Randy Clarida and Michelle Haamid records pertai . . .

Investigators slap MedImmune U.K. with 14-item 483.(BLOOD AND BIOLOGICS)
MedImmune U.K., Speke, Liverpool, UK CBER MedImmune U.K. received a 14-item 483 following an inspection March 21-23 and 26-29, 2007, by FDA investigators Mihaly Ligmond, Omotunde Osunsanmi and Ste . . .

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 I . . .

New drug GMPs, tobacco rules, Part 11 emphasis and return to old warning letter policy seen possible under Obama's FDA.
Drug, device and biologics manufacturers can expect a reversal of several Bush administration policies as they relate to FDA enforcement as soon as President Obama names an FDA Commissioner, which c . . .

Pascal receives 17-item 483 for sterility, cleanliness and testing failures.(HUMAN DRUGS)
Pascal Company, Bellevue, WA 03/28-04/18/2006 Seattle District FDA investigators Brenda Rohring and Terri Dodds, working with chemist Randy Self, cited Pascal's drug manufacturing facility for 17 . . .

FDA cites Unigen for testing, procedure and record-keeping flaws.(HUMAN DRUGS)
Unigen Pharmaceuticals, Westminster, MD Baltimore District Drug maker Unigen Pharmaceuticals received an 18-item 483 following investigator Brooke Seeman's inspection of its facility March 5-22, 2 . . .

Wallach receives 10-item 483 for device design, process control issues.(MEDICAL DEVICES)
Wallach Surgical Devices, Orange, CT New England District Following an inspection of Wallach Surgical Devices' facility June 6-9, 2006, FDA investigators Elizabeth Griffin and Anthony Onianawa iss . . .

Medtronic Neurological draws 9-item 483 for design input, production process issues.(MEDICAL DEVICES)
Medtronic Neurological, Minneapolis, MN Minneapolis District During their inspection of Medtronic Neurological conducted during May and June of 2006, FDA investigator Kellie Westerbuhr and Complia . . .

Zawada avoids 483 but protocol deviations noted.(CLINICAL INVESTIGATORS)(Clinical report)
Edward Zawada, M.D., Avera Research Institute, Sioux Falls, SD, Minneapolis District An FDA inspection covering three separate clinical study protocols conducted by Edward Zawada, M.D., Avera Rese . . .

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 I . . .

House Commerce panel chiefs introduce FDA Globalization Act to boost agency authority.
Four leading House Commerce Committee Democrats introduced the FDA Globalization Act Jan. 28, which a statement from one congressman's office described as a "critical step toward equipping [FDA] wit . . .

Amerifit Pharma slapped with 26-item 483 for failure to follow procedures.(HUMAN DRUGS)
Amerifit Pharma, Woburn, MA New England District After inspecting Amerifit Pharma's drug manufacturing facility from April 10-May 10, 2007, FDA investigator Debra Emerson issued a 26-item 483, cit . . .

Amneal cited for lapses on OOS batches, annual reviews.
Amneal Pharmaceuticals, Paterson, NJ Parsippany District During his inspection of Amneal Pharmaceuticals July 5-17, 2007, FDA investigator Douglas Kovacs found that the drug manufacturer had not s . . .

FDA issues 6-item 483 to Ben Venue for testing, cleaning flaws.
Ben Venue Laboratories, Bedford, OH Cincinnati District FDA investigators Mark Parmon and Stephen Kilker inspected Ben Venue Laboratories May 7-June 15, 2007, observing GMP violations in several a . . .

National Biological nets 14-item 483 for CAPA, design control failures.(DEVICES)
National Biological Corp., Beachwood, OH Cincinnati District Medical device manufacturer National Biological Corp. was faulted for numerous problems with its corrective and preventive action (CAPA . . .

Bentec Medical receives 5-item 483 for gaps in study oversight.(CLINICAL INVESTIGATORS/SPONSORS)
Bentec Medical, Woodland, CA San Francisco District Bentec Medical failed to file an IDE application or obtain FDA approval to conduct a study using the GaBP ring device, investigator Shelley Robe . . .

Davis investigation garners 11 items on 483.(CLINICAL INVESTIGATORS/SPONSORS)
Thomas Davis, M.D., Detroit, MI Detroit District A clinical study involving an investigational device for which Thomas Davis, M.D., served as principal investigator failed to obtain an IDE before . . .

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 I . . .

FDA looks ahead to legislation to provide resources and authority to secure drug products.
CORONADO, CA -- FDA is awaiting potential legislation that would give the agency more power, resources and tools to ensure a safe supply chain for drugs and biologics, administration representatives . . .

FDA finds control, testing issues at Anacapa Technologies.(HUMAN DRUGS)
Anacapa Technologies, San Dimas, CA Los Angeles District Drug manufacturer Anacapa Technologies received a three-item 483 from FDA investigator Virgilio Facio following an inspection July 16-23, 2 . . .

Neil Laboratories flaws attributed to lack of oversight.(HUMAN DRUGS)
Neil Laboratories, East Windsor, NJ Parsippany District Neil Laboratories received an eight-item 483 following an inspection in which FDA said several of the observations "were directly tied to br . . .

Vintage Pharmaceuticals cited for laboratory and process failures.(HUMAN DRUGS)
Vintage Pharmaceuticals, Huntsville, AL Nashville District FDA investigator Lesley Satterwhite faulted Vintage Pharmaceuticals for problems with laboratory controls and records, test devices and p . . .

Validation problems and FDA reporting lapses result in 8-point 483 for Stryker.(MEDICAL DEVICES)
Stryker Orthopaedics, Mahwah, NJ Parsippany District Stryker was cited for failing to submit reports of corrections and removals to FDA when recalling out-of-specification orthopedic implants, amo . . .