Inspections, Compliance, Enforcement, and Criminal Investigations
2001 Warning Letters
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Warning Letters for 2001
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* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.
Read more about warning and close-out letters
Posted on May 26, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
May 04, 2001 | Prpctor & Gamble | San Juan District Office | CGMP for Finished Pharmaceuticals/Human Drug Manufacturing Facility/Adulterated | N/A * |
May 04, 2001 | Material Resources LLC | Chicago District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
May 04, 2001 | Oriental Food Marketing Inc. | New England District Office | Seafood HACCP | N/A * |
May 04, 2001 | Golden International Import Export Corporation | Seattle District Office | Seafood HACCP | N/A * |
May 04, 2001 | Procter & Gamble | San Juan District Office | CGMP for Finished Pharmaceuticals/Human Drug Manufacturing Facility/Adulterated | N/A * |
May 04, 2001 | Puretone Ltd. | Center for Devices and Radiological Health | Quality System Regulation/Adulterated | N/A * |
May 03, 2001 | Tyler Memorial Hospital | Philadelphia District Office | Mammography Quality Standards | N/A * |
May 03, 2001 | Permobil AB | Center for Devices and Radiological Health | Powered Wheelchair/Quality System Regulation | N/A * |
May 03, 2001 | HCA The Healthcare Company | Denver District Office | CGMP/Blood & Blood Components | N/A * |
May 03, 2001 | Lansdale Medical Group P.C. | Philadelphia District Office | Mammography Quality Standards | N/A * |
May 02, 2001 | Lourdes Medical Center | Seattle District Office | Mammography Quality Standards | N/A * |
May 01, 2001 | Dark Hollow Foods | Baltimore District Office | Good Manufacturing Practices for Acidified Foods/Adulterated | N/A * |
May 01, 2001 | DFW International Airport | Dallas District Office | Airline Support Facility/Interstate Conveyance Sanitation | N/A * |
May 01, 2001 | COATS Aloe International Inc. | Dallas District Office | CGMP for Finished Pharmaceuticals/Drug and Cosmetic Manufacturing Facility/Adulterated | N/A * |
April 30, 2001 | Lakeland Medical Associates | Dallas District Office | Mammography Quality Standards | N/A * |
April 30, 2001 | Larson's Dairy Inc. | Florida District Office | Drug Residues/Edible Tissues/Adulterated | N/A * |
April 30, 2001 | County Distributors Inc. | New England District Office | Seafood HACCP | N/A * |
April 27, 2001 | Group Health Cooperative-Eastside Hospital | Seattle District Office | Mammography Quality Standards | N/A * |
April 27, 2001 | Maruwa Skokai Guam Inc. | Los Angeles District Office | Seafood HACCP | N/A * |
April 27, 2001 | Johnson Donald R. M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
April 27, 2001 | Wilson N. Jones Women's Imaging Center | Dallas District Office | Mammography Quality Standards | N/A * |
April 27, 2001 | Alaska Garden and Pet Supply Inc. | Seattle District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
April 27, 2001 | Meiko Food Company | Los Angeles District Office | Seafood HACCP/CGMP/Misbranded | N/A * |
April 26, 2001 | Women's Center of Lexington | Atlanta District Office | Mammography Quality Standards | N/A * |
April 26, 2001 | Richardson Labs Inc. | Center for Food Safety and Applied Nutrition | Unapproved Food Additive/Unauthorized Nutrient Content Claim | N/A * |
April 26, 2001 | Rabun County Memorial Hospital | Atlanta District Office | Mammography Quality Standards | N/A * |
April 25, 2001 | VEGA Grieshaber KG | Atlanta District Office | Device Lacks Marketing Clearance Approval/Adulterated/Misbranded | N/A * |
April 25, 2001 | Biological Technologies International Inc. | Center for Devices and Radiological Health | Lacks Premarket Notification/Adulterated/Misbranded | N/A * |
April 25, 2001 | Lime Creek Ag Services Inc. | Minneapolis District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
April 25, 2001 | Colgate-Pamolive Company | New York District Office | NDA Fails To Bear Adequate Directions/Misbranded | N/A * |
April 25, 2001 | Janice's Kitchen | Baltimore District Office | Seafood HACCP/Deviled Crab Processing Facility | N/A * |
April 25, 2001 | Natural Health Consultants | Center for Devices and Radiological Health | Lacks Premarket Notification/Adulterated/Misbranded | N/A * |
April 25, 2001 | Lucky International Trading Inc. | Kansas City District Office | Food Storage Warehouse/Insanitary Conditions/Adulterated | N/A * |
April 25, 2001 | BioEclectic Research | Center for Devices and Radiological Health | Device /Lacks Marketing Clearance Approval/Adulterated/Misbranded | N/A * |
April 25, 2001 | Western Plains Medical Complex | Dallas District Office | Mammography Quality Standards | N/A * |
April 25, 2001 | LSG Sky Chefs Inc. | Dallas District Office | Airline Catering Facility/Insanitary Conditions | N/A * |
April 24, 2001 | Albermarle Hospital | Atlanta District Office | Mammography Quality Standards | N/A * |
April 24, 2001 | Med-Pharmex Inc. | Los Angeles District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | N/A * |
April 24, 2001 | Waldron Smokehouse Specialties Inc. | Seattle District Office | Seafood HACCP | N/A * |
April 24, 2001 | Marshall Regional Medical Center | Dallas District Office | Mammography Quality Standards | N/A * |
April 23, 2001 | HealthCrest | Center for Devices and Radiological Health | Fertility Awareness Kit-The Lens/Lacks Premarket Notification/Misbranded/Adulterated | N/A * |
April 23, 2001 | White County Hospital | New Orleans District Office | Mammography Quality Standards | N/A * |
April 23, 2001 | R & G Medical and Development Corporation | Center for Devices and Radiological Health | Self Pap/Lacks Premarket Notification/Adulterated/Misbranded | N/A * |
April 23, 2001 | Earl B. Olson Feed Mill | Minneapolis District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
April 20, 2001 | Club Fitness | Dallas District Office | Tanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded | N/A * |
April 20, 2001 | Grafor Manufacturing Inc. | San Juan District Office | Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated | N/A * |
April 20, 2001 | St. Joseph's Imaging Associates | New York District Office | Mammography Quality Standards | N/A * |
April 19, 2001 | Fresh Island Fish Company Inc. | San Francisco District Office | Seafood HACCP/Histamine Forming Fish/Adulterated | N/A * |
April 19, 2001 | Accent Health Care | Chicago District Office | CGMP/Liquid Oxygen/Adulterated | N/A * |
April 19, 2001 | Green Turtle Cannery | Florida District Office | Low Acid Canned Food Regulation/Adulterated | N/A * |
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