FDA Warning Letters 2017
FDA Warning Letters 2017 is a post summarizing last year’s Warning Letters. Each year the FDA releases an enforcement report along with a summary of Inspectional Observations from the previous fiscal year. As an FDA attorney, it is important for my firm to understand enforcement trends to help clients respond to a range of FDA enforcement issues. That’s why ahead of the release of the enforcement report I combed through the FDA Warning Letters 2017. The Warning Letters were pulled from the FDA’s public page and tabulated to look at what categories garnered FDA enforcement attention.
Total Numbers
A total of 504 Warning Letters were issued in 2017. The first Warning Letter was sent on January 5, 2017, and the last Warning Letter was issued on December 29, 2017.
Geography
The first metric assessed was where the FDA Warning Letters 2017 was issued. It’s important to note some Warning Letters are issued by District Offices and others by Centers in Washington D.C. This is a little imprecise since it won’t tell us whether a Warning Letter issued by a District Office involved one more Centers signing off or the issues involved. Still, it can provide insight into how Warning Letters are issued, hot spots for inspections, and the overall focus of the FDA (i.e. more Tobacco letters this year tells us the new Deeming Regulation was a high enforcement priority).
Here are the FDA Warning Letters 2017 by the location of issuance:
| CBER | 1 | 0.20% | |
| CDRH | 15 | 2.98% | |
| CDER | 83 | 16.47% | |
| CFSAN | 14 | 2.78% | |
| CTP | 81 | 16.07% | |
| CVM | 1 | 0.20% | |
| Chicago DO | 17 | 3.37% | |
| Cincinnati DO | 13 | 2.58% | |
| Dallas DO | 34 | 6.75% | |
| Denver DO | 16 | 3.17% | |
| Detroit DO | 15 | 2.98% | |
| Florida DO | 10 | 1.98% | |
| Kansas City DO | 14 | 2.78% | |
| L.A. DO | 51 | 10.12% | |
| Minneapolis DO | 9 | 1.79% | |
| New England DO | 11 | 2.18% | |
| New Jersey DO | 23 | 4.56% | |
| New Orleans DO | 6 | 1.19% | |
| New York DO | 27 | 5.36% | |
| Philadephia DO | 6 | 1.19% | |
| San Francisco DO | 12 | 2.38% | |
| San Juan DO | 8 | 1.59% | |
| Seattle DO | 16 | 3.17% | |
Warning Letters issued by CDER and CTP (Center for Tobacco Products) lead by a wide margin. CTP jumped to the front of the pack thanks to the Deeming Regulation. The L.A. district led the district offices in issuing Warning Letters followed by Dallas, then New York. It’s interesting to note Dallas issued more Warning Letters than New York, Atlanta, or New Jersey. Dallas is clearly a big and very busy district.
Topics
A more helpful metric is to look at why a Warning Letter was issued. FDA Warning Letters 2017 cited 71 distinct categories of violations. Those are provided in full in the table below. To parse through the regulatory maze a simplified table is also below. The simplified table attempted to group the regulatory citations into common categories, like food/dietary supplement, cosmetic, medical, device or drug, and broad categories like GMPs (adulteration) and claims (misbranding).
FDA Warning Letters issued to food companies immediately jumps out as a major player. The Center for Food Safety and Applied Nutrition (CFSAN) only issued 14 Warning Letters directly but nearly 30% of FDA Warning Letters 2017 were issued for food or dietary supplement violations. Nearly 10% of those were issued to seafood companies alone. It’s clear that the enforcement of food safety regulations, including dietary supplement claims, is a major priority and one largely taken on at the District Office level.
Again the Deeming Regulation was a clear priority with all of the CTP Warning Letters appearing to cite sales to minors from e-cig/vape retailers. All of the Warning Letters were issued by CTP directly implying a strict protocol over citing Deeming Regulation violations.
There were a high number, around 6, Warning Letters issued for a refusal to inspect a facility. This is an unusual violation that carries significant risk.
The Center for Devices and Radiological Health also appears to rely on the District Offices. CDRH only issued 15 Warning Letters directly but a total of 41 Warning Letters were issued. The heavy number of adulteration/GMP Warning Letters may explain the trend.
No surprise all the Warning Letters issued to cosmetic companies were for claims that qualified as new drug claims since GMPs are not mandatory.
Several Warning Letters were issued to Cannabidiol(CBD) products for misbranding.
Overall, it was a busy year for Warning Letters and by looking back at 2017 there are lessons to learn, which should help industry avoid the pitfalls others fell into.
| Simplified Categories | ||
| Total Food and Dietary Supplment | 148 | 29% |
| GMPs | 96 | 19% |
| Cliams | 50 | 10% |
| Total Cosmetic | 4 | 1% |
| GMPs | 0 | 0% |
| Claims | 4 | 1% |
| Total Tobacco | 80 | 16% |
| Deeming Regulations | 80 | 16% |
| Total Medical Device | 41 | 8% |
| GMPs | 37 | 7% |
| Claims | 4 | 1% |
| Total Animal | 11 | 2% |
| Drugs | 8 | 2% |
| Food/Feed | 3 | 1% |
| Total Drug | 101 | 20% |
| GMPs | 86 | 17% |
| Claims | 15 | 3% |
| Other | 7 | 1% |
| 71 Total Categories | ||
| Unapproved New Drugs/Misbranded | 46 | 9.13% |
| Unapproved New Drug/Compounding/Misbranding/Adulterated | 1 | 0.20% |
| Unapproved New Animal Drug/Adultered/Misbranded/Misleading | 3 | 0.60% |
| Sponsor/Investrigator | 3 | 0.60% |
| Seafood HACCP/CGMP for Foods/Adulterated/Misbranded | 50 | 9.92% |
| Processing and Bottling of Bottled Drinking Water Regulation/Insanitary Conditions | 1 | 0.20% |
| Premarket Approval/Misbranded/Adulterated | 1 | 0.20% |
| PHS Act/Shell Egg Regulation/Adulterated | 1 | 0.20% |
| New Drugs/Dietary Supplements/Food Labeling/Misbranded | 2 | 0.40% |
| New Drugs/Cosmetics Labeling and Marketing with Drug Claims | 1 | 0.20% |
| New Drug/Misbranded/Cannabidiol(CBD) products | 4 | 0.79% |
| New Drug/Misbranded | 9 | 1.79% |
| New Drug/Labeling/Misbranded | 7 | 1.39% |
| New Drug/Labeling/False & Misleading Claims | 1 | 0.20% |
| New Drug/Labeling | 1 | 0.20% |
| New Animal Drug/Adulterated | 4 | 0.79% |
| Medical Foods/Unapproved New Drug/Misbranded | 1 | 0.20% |
| Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | 1 | 0.20% |
| Medical Device Reporting/Misbranded | 1 | 0.20% |
| Low Acid Canned Food Regulation/Adulterated | 4 | 0.79% |
| Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded | 1 | 0.20% |
| Juice/HACCP/Adulterated | 4 | 0.79% |
| Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | 9 | 1.79% |
| Interstate Conveyance Sanitation Regulations | 1 | 0.20% |
| Internet Marketing of Unapproved and Misbranded Drugs | 1 | 0.20% |
| Illegal Drug Residue Animal Tissue/Adulterated | 5 | 0.99% |
| Illegal Drug Residue | 8 | 1.59% |
| Food/Egg/Prepared Packed or Held Under Insanitary Conditions/Adulterated | 2 | 0.40% |
| Food/Edible Tissue/Drug Residue/Adulterated | 1 | 0.20% |
| Finished Pharmaceuticals/Misbranded | 1 | 0.20% |
| Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | 80 | 15.87% |
| Failure to Register and List | 2 | 0.40% |
| Failure to Comply with Drug Listing Requirements/Misbranded | 1 | 0.20% |
| Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | 1 | 0.20% |
| Drug Product/Adulterated | 13 | 2.58% |
| Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded | 2 | 0.40% |
| Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | 3 | 0.60% |
| Compounding Pharmacy/Adulteration/Misbranding | 4 | 0.79% |
| Compounding Pharmacy/Adulterated Drug Products | 37 | 7.34% |
| Clinical Investigator | 4 | 0.79% |
| CGMP/QSR/Medical Devices/Adulterated/Misbranded | 2 | 0.40% |
| CGMP/QSR/Medical Devices/Adulterated | 25 | 4.96% |
| CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | 1 | 0.20% |
| CGMP/QSR/Drug/Medical Devices/Adulterated | 1 | 0.20% |
| CGMP/Medicated Feeds/Adulterated | 1 | 0.20% |
| CGMP/Manufacturing, Processing, packing, or Holding/Misbranding | 1 | 0.20% |
| CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | 4 | 0.79% |
| CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | 7 | 1.39% |
| CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | 3 | 0.60% |
| CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | 10 | 1.98% |
| CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded | 1 | 0.20% |
| CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded | 1 | 0.20% |
| CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | 5 | 0.99% |
| CGMP/Finished Pharmaceuticals/Adulterated/Refused Inspection | 1 | 0.20% |
| CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | 6 | 1.19% |
| CGMP/Finished Pharmaceuticals/Adulterated | 42 | 8.33% |
| CGMP/Drugs/Adulterated | 1 | 0.20% |
| CGMP/Drug Products/Adulterated | 1 | 0.20% |
| CGMP/Dietary Supplement/Adulterated/Misbranded | 24 | 4.76% |
| CGMP/Dietary Supplement/Adulterated | 3 | 0.60% |
| CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Refused Inspection | 2 | 0.40% |
| CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded | 3 | 0.60% |
| CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | 19 | 3.77% |
| CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | 7 | 1.39% |
| CGMP Deviations/Current Good Tissue Practice (CGTP) | 1 | 0.20% |
| Animal Drugs/Adulterated | 1 | 0.20% |
| Adultered Animal Food/Misbranded | 2 | 0.40% |
| Adulterated Dietary Supplements, Unapproved New and Misbranded Drugs | 1 | 0.20% |
| Acidified Foods/Prepared Packed or Held Under Insanitary Conditions | 2 | 0.40% |
| Acidified Foods/Emergency Permit Control/Adulterated/Misbranded | 3 | 0.60% |
| Acidified Foods/Adulterated | 1 | 0.20% |
**Disclaimer: Marc C. Sanchez, Esq. is a FDA attorney in private practice and the above is not intended as legal advice. FDA Atty law firm is hosting this blog solely for educational purposes.**
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