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 for sale in previous editions of Inspection Monitor, but most are newly obtained inspection records, guidelines, etc. Documents are listed by product area, such as Human Drugs, Medical Devices and Blood & Biologics. Please order documents by the RECORD-RETRIEVE order number (i.e., 109493M). You can call (703) 779-8777 to order by phone, fax us at (703) 779-2508, by email, Service@FDAINFO.COM or online at www.FDAINFO.com. No pre-payment is necessary (except subscribers outside North America and nonsubscribers). You also may pay by purchase order or credit car. RECORD-RETRIEVE charges $25 for retrieval including U.S. shipping. This charge is assessed PER ORDER, not per document. Human Drugs 483s, EIRs Doc. # Price Allergy Laboratories, Oklahoma City, 109855M $6.00

OK, 8/9-29/05, 103-7, 25/05 Alwyn, Lake Crystal, MN, 4/30-5/7/03 109830M $9.50 American I.V. Products, Hanover, MD, 109857M $6.50

7/29-8/17/05 American Peptide Company, Vista, CA, 109838M $3.00

8/12-16/05 Ameri-Pac, St. Joseph, MO, 4/27-5/13/04 109828M $5.00 Andrix Pharmaceuticals, Ft. Lauderdale, 109849M $5.50

FL, 3/16-4/18/06 Aveda, Minneapolis, MN, 2/23-3/1/04 109829M $4.00 Bausch & Lomb, Greenville, SC, 3/22-5/15/06 109389M $4.00 Ben Venue Laboratories, Bedford, Oh, 2/13-16/06 109874M $7.50 Bioniche, Teo, County Galway, Ireland 109891M $12.50 Boehringer Ingelheim Vetmedica, Elwood, 109810M $3.50

LS, 7/19-29/04 Cambridge Major Laboratories, Germantown, 109873M $17.50

WI, 11/2-9/05 Cassidy, St. Paul, MN, 1/7-9/04, 1/5-9/06 109831M $9.00 Central Admixture Pharmacy Services, Santa Fe 109825M $11.50

Springs, CA, 11/16-18/04, 6/14-15/05 Cima Laboratories, Brooklyn Park, 109820M $8.50

MN, 7/21-8/1/03, 7/14-15/04 Classic Cosmetics, Chatsworth, CA, 3/4-11/04 109821M $5.50 Crown Laboratories, Johnson City, 109816M $75.50

TN, 1/7-14/03, 4/6-21/04, 9/6-16/05 Diversified Manufacturing Corp., Newport, 109811M $4.50

MN, 3/5-10/05 Greer Laboratories, Lenoir, NC, 2/14-3/3/05 109872M $25.50 I Shay Cosmetics, Hawthorne, CA, 2/5-9/04 109824M $3.00 Kutol Products, Cincinnati, OH, 7/17-20/03 109866M $17.50 Lupitold Pharmaceuticals, Shirley, NY, 6/13-27/05 109880M $15.50 Maple Island, Wanamingo, 109850M $15.00

MN, 6/25-26/03, 5/24-26/04 Pharmaceutical Specialties, Rochester, 109832M $4.00

MN, 7/20-29/05 Southern Meds Joint Venture, Biloxi. 109851M $5.50

MS, 8/3-11/05 Taro Pharmacecutical Industries, Haifa Bay, 109818M $35.00

Israel, 10/27-31/02 Tyco Healthcare, St. Louis, MO, 11/2-4/05 109823M $3.00 Shasun Chemicals & Drugs, Ltd., Pondicherry, 109888M $9.50

India, 10/31-11/3/00 Vi Jon Laboratories, St. Louis, 109865M $21.50

MO, 9/1-5/03, 3/24-25/05 Yamanouchi Pharmaceutical, Takahagi, Ibaraki, 109817M $30.00

Japan, 8/20-22/03, 11/8-11/04 Medical Devices 483s, EIRs Doc. # Price Advanced Imagining Research, Cleveland, 109867M $8.50

Oh, 2/6-13/06 American Medical Systems, Minnetonka, 109822M $3.00

MN, 4/28-5/11/05 Banner Pharmcaps, High Point, NC, 3/3-15/04 109790M $12.50 CareFore Medical Incorporate, Olathe, KS 109890M $3.00 Carolina Liquid Chemistries Corporation, Brea, 109840M $6.00

CA, 10/26-11/8/05 Diazyme Laboratories Division, General Atomics, 109842M $11.50

San Diego, CA, 10/31-11/9/05 EM Innovations, Galloway, OH, 2/7-10/06 109881M $3.00 Lifecore Biomedical, Chaska, MN, 5/12-24/05 109843M $8.50 Multidata Systtems International Corp., 109858M $6.00

St. Louis, MO, 3/8-24/04 OrthoHelix Surgical designs, Akron, 109882M $4.50

OH, 1/10-31/06 Pharmaceutical Specialties, Rochester, 109832M $4.00

MN, 7/2-29/05 PCI Technology, Dallas, TX, 8/15-31/05 109886M $3.00 RA Medical Systems, Carlsbad, CA, 10/11-25/05 109859M $7.50 Ram Precision Industries, Centerville, 109812M $6.00

OH 8/16-30/05 Resonance Technology, Northridge, CA, 1/26-27/06 109841M $4.50 Restorative Health Services, Nashville, 109860M $5.50

TN, 10/11-25/05 Shelhigh, Union, NJ, 4/28-5/16/05 109868M $16.50 Southern Florida Bioavailability Clinic 115335 $25.00

Int'n., Miami, FL, 7/29-8/4/03, 7/20-23/04,

3/29-5/2/05 Theken Spine LLC, Akron, OH, 6/5-9/06 109869M $8.50 USSC Puerto Rico, Mercedita, PR, 11/3-12/10/04 109887M $3.00 Utah Medical Products (UTMD), Midvale, UT 109889M $10.50 Blood & Biologics 483s, EIRs Doc. # Price Bio-Concept Laboratories, Derry, NH, 11/14-18/05 115317 $3.00 BioLife Plasma Services, Ruston, LA, 1/5/06 109834M $3.00 Chesapeake Biological Laboratories, Baltimore, 109808M $134.00

MD, 10/18-11/15/04, 1/20-2/3/05, 5/27-6/6/05 Covance Laboratories, Madison, WI, 1/13-2/10/05 115316 $17.00 GenTrac, Middleton, WI, 6/20-23/05 109875M $3.00 International BioResources, Milwaukee, 109876M $7.50

WI, 11/16-28/05 Sanofi Pasteur, Swiftwater, PA, 4/18-28/06 109852M $6.50 ViaCord, Boston, MA, 8/26-27/96 109885M $3.00 Sponsors/Monitors 483s, EIRs Doc. # Price Orthometrix, White Plains, NY, 1/6, 10, 24-3/4/05 115338 $8.50 Clinical Investigators 483s, EIRs Doc. # Price Agren, Stuart, M.D., Family Allergy Center, 115307 $6.00

Mesa, AZ, 1/18-19, 24/05 Bailey, Charles, Orlando, FL, 5/20-22/03 115315 $5.00 Cohen, Daniel, M.D., Boston, MA, 1/20-28/05 109798M $8.00 Coury, Daniel, M.D., Columbus, OH, 1/5-26/05 115306 $9.50 Frost, Adaani, M.D., Houston, TX, 10/18-21/05 115325b $3.00 Gonzalez, Christine, M.D., Los Angeles, 115310 $3.00

CA, 7/12-16/04 Herbert, Corey, M.D., New Orleans, LA, 3/17-22/05 109799M $9.00 Johnson, Miers, M.D., 3/22-26/04 115320 $20.00 Lesem, Michael, M.D., Claghorn-Lesem Research 115308 $3.50

Clinic, Houston, TX, 3/15-19/04 Lobuglio, Albert, M.D., Georgia Cancer 109780M $4.50

Specialists, Atlanta, GA, 11/3-10/03 McLeod, Jeffrey, M.D., Midlothian, 115325 $3.00

VA, 7/24-8/6/03 Rich, Paul, M.D., Milwaukee, WI, 6/15-22/04 109781M $5.00 Rossner, Stephen, M.D., Wallingford, 115337 $15.50

CT, 3/4-10/05 Rowen, Sheri, M.D., Baltmore, MD, 5/12-6/2/05 115321 $6.00 Schwartzberg, Lee, M.D., Memphis. TN, 2/18-3/5/05 115322 $22.00 Wu, Alan, H.B., Ph.D., Hartford Hospital, 115343 $3.00

Hartford, CT, 2/28-3/2/00 GLPs/CROs/Contract Labs 483s,EIRs Doc# Price Battelle Memorial Institute, Columbis, 115330 $9.00

OH, 1/6-27/04 Bio-Concept Laboratories, Derry, NH, 11/14-18/05 115317 $3.00 Celsis Laboratory Group, St. Louis, 115326 $10.25

MO, 6/13-17/05 Charles River Labs Discovery and Development 109782M $18.00

Services, Worcester, MA, 9/8-23/03 Covance Laboratories, Madison, WI, 1/13-2/10/05 115316 $17.00 Formatech, Inc., Andover, MA, 5/17-18/05 115340 $8.00 Galbreth Labs, Knoxville, TN, 12/20-22/04 109783M $5.50 Medtronic Physiological Research Lab, 115318 $3.00

Minneapolis, MN, 9/19-29/05 PPD Development, Austin, TX, 7/12/05 115331 $8.00 PPD Development, Middleton, WI, 7/12-15/04 115305 $5.00 Southern Florida Bioavailability Clinic 115335 $25.00

International, Miami, FL, 7/29-8/4/03,

7/20-23/04, 3/29-5/2/05 University of Iowa Bone Healing Lab, Iowa 115342 $3.00

City, IA, 2/4/05 IRBs 483s,EIRs Doc# Price Baltimore City Health Department IRB, Baltimore, 115327 $3.00

MD, 8/22-29/05 Chesapeake Research Review, Columbia, 115311 $9.50

MD, 1/5-9/04 Covance Clinical Research Unit IRB, Madison, 115341 $5.50

WI, 1/13-14, 16/04 Other Documents of Interest 483s,EIRs Doc# Price Rivera, Edwin, FDA Top 10 Citations 2005 109826M $20.00