FDA Enforcement and Recall Report Week of June 27
Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters.
This past week brought one of the more diverse series of recalls since in several weeks. It may be a sign the latest listeria recall is smaller in scope. It could also be the recall is just beginning to take shape. This past week a total of 18 notices posted, with 7 exclusively due to listeria and and another animal product recalled due to listeria and salmonella. Undeclared allergens followed with an equal number of 7 recall notices, largely due to peanuts. This is down from the 9 undeclared allergen postings from the previous week. As discussed before undeclared allergens points to lapses in the GMP program. Under FSMA the GMP program along with the hazard analysis under HARPC is expected to mitigate the number of undeclared allergen recalls. This rule takes effect in the autumn. Facilities need to update GMP procedures to ensure FDA compliance. Other recalls posted due to botulism in canned sardines, a risk of spoilage from Bolthouse Farms protein beverages, and salmonella in raw nuts. The risks of salmonella in raw nuts would also be an issue for FSMA under the Foreign Supplier Verification Program. Under this FSMA rule an importer would need to assess who controls the risk – which in the case of raw nuts sold to consumers will frequently be the foreign supplier. Understanding FSVP risk control will be crucial to FDA compliance.
FDA Warning Letters – GMPs
This week 11 Warning Letters posted. GMP lapses dominated with 8 of the 11 related to GMP or HACCP problems. Three of the Warning Letters addressed seafood or juice HACCP non-compliance. Juice and seafood HACCP is typically strictly followed making warning letters a sign of serious issues in the FDA compliance culture. The other five related to dietary supplement, medical device, and drug GMP issues. The other warning letters related to illegal drug residue in animal production, unapproved new drugs in a compounding pharmacy, and a clinical investigator’s non-compliance. Compounding pharmacies continue to make an apperance on the warning letter list since the new regulation. Oversight of this corner of the drug industry shows signs of increased focus and a need to monitor FDA compliance carefully.
Please contact our Washington D.C. or Research Triangle, NC office with any FDA recall, Warning Letter or other enforcement questions.
Recalls Week of June 27
|06/24/2016||Nature Valley||Protein Chewy Bars and Simple Nut Bars||Listeria monocytogenes||General Mills|
|06/24/2016||GFS||Cheesecakes||Undeclared peanuts||The Father’s Table|
|06/24/2016||Fresh Market||Smoked TFM Supreme Nut Mix Bags||Undeclared peanuts and soy||Creative Snack Co.|
|06/24/2016||Snack Shoppe, Figi’s, Nature’s Mix||Snack Mixes||Due to Listeria monocytogenes contamination||Figi’s Companies, Inc.|
|06/23/2016||Honey Maid||Mondelēz Global LLC||Undeclared peanut||Mondelēz Global LLC|
|06/23/2016||Rad Cat||Raw cat food||Salmonella, Listeria monocytogenes||Radagast Pet Food, Inc.|
|06/23/2016||Michael’s Naturopathic Programs||Dietary Supplements||Undeclared milk and soy||Michael’s Naturopathic Programs|
|06/23/2016||Atlantic Spice Co.||Sunflower Seeds Roasted Salted, Tropical Mix and Cranberry Health Mix snacks||Listeria monocytogenes||Atlantic Spice Company Inc.|
|06/22/2016||Bolthouse Farms||Protein beverages||Due to possible spoilage||Bolthouse Farms|
|06/22/2016||Lance||Oyster crackers||Undeclared peanut||Snyder’s – Lance, Inc.|
|06/21/2016||Whole Foods Market||Raw Macadamias||Salmonella||Marin Foods Specialties, Inc.|
|06/21/2016||Al Rasheed||Sardine||Potential for botulism||Greenland Trading Corporation|
|06/21/2016||C & W||Early Harvest Petite Peas and Petite Peas||Listeria monocytogenes||Pinnacle Foods Inc.|
|06/21/2016||Dutch Treat Foods, Inc.||Sweet Pea Pasta Salad||Listeria monocytogenes||Dutch Treat Foods, Inc.|
|06/21/2016||Spartan (for cheese cake)||cheese cake||Undeclared peanut||SpartanNash|
|06/21/2016||Tippin’s||Key Lime Pie||Undeclared Peanut||Tippin’s Gourmet Pies, LLC|
|06/20/2016||Bountiful Harvest, First Street, Great Value, more||Frozen green peas and frozen mixed vegetables||Listeria monocytogenes||National Frozen Foods Corporation|
|06/19/2016||Integrated Food Service||Ready-To-Eat Sandwiches||Listeria monocytogenes||Let’s Do Lunch, Inc., DBA Integrated Food Service|
Warning Letters Week of June 27
|May 27, 2016||MGM Cattle Co. LTD||Dallas District Office||Illegal Drug Residue||Not Issued *|
|May 24, 2016||American Pure Whey||Atlanta District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|June 16, 2016||Adriatic Seafood Inc||New York District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|June 14, 2016||Suisan Company, Ltd||San Francisco District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|June 13, 2016||S.R. Burzynski Manufacturing Facility||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|June 07, 2016||Millers of Wyckoff, Inc.||New Jersey District Office||CGMP/Finished Pharmaceuticals/Adulterated/Misbranded||Not Issued *|
|June 03, 2016||Qualgen||Dallas District Office||Unapproved New Drug/Compounding/Misbranding/Adulterated||Not Issued *|
|June 02, 2016||TYRX Inc.||New Jersey District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|June 02, 2016||Valley Processing, Inc.||Seattle District Office||Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|February 04, 2016||Berwickshire Electronic Manufacturing Ltd.||Center for Devices and Radiological Health||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|April 14, 2016||Neuralight HD, LLC||Center for Drug Evaluation and Research||Sponsor/Investigator||Not Issued *|
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