Devine Guidance

The Twelve Days of Christmas: Not Exactly!

By Dr. Christopher Joseph Devine
December 21, 2015


• Categories: 05-Quality/Regulatory, Devine Guidance, RC - Medtech Regulatory Resource Center

With Christmas rapidly approaching, Dr. D hopes all of the readers that celebrate Christmas have completed their shopping. FYI, Dr. D has not but will begin shopping with a vengeance ASAP. For this week’s guidance, the doctor will change things up a bit and share a song with the readers. Please remember to keep the song “The Twelve Days of Christmas” written by Frederic Austin (English composer) in 1909 in mind. The doctor is quite sure that my version will have Mr. Austin rolling over in his proverbial grave as Dr. D revises this objet trouvé (look-it-up) and gives it new meaning. Enjoy!

Twelve Days of Christmas

1. On the first day of Christmas the FDA gave to me, a copy of a consent decree.
2. On the second day of Christmas the FDA gave to me, two U.S. Marshalls, and a copy of a consent decree.
3. On the third day of Christmas the FDA gave to me, three warning letters, two U.S. Marshalls, and a copy of a consent decree.
4. On the fourth day of Christmas the FDA gave to me, four product seizures, three warning letters, two U.S. Marshalls, and a copy of a consent decree.
5. On the fifth day of Christmas the FDA gave to me, FIVE Form 483s; four product seizures, three warning letters, two U. S. Marshalls and a copy of a consent decree.
6. On the sixth day of Christmas the FDA gave to me, six investigators inspecting, FIVE Form 483s; four product seizures, three warning letters, two U.S. Marshalls, and a copy of a consent decree.
7. On the seventh day of Christmas the FDA gave to me, seven MedWatch alerts, six investigators inspecting, FIVE Form 483s; four product seizures, three warning letters, two U. S. Marshalls, and a copy of a consent decree.
8. On the eight day of Christmas the FDA gave to me, eight enforcement reports, seven MedWatch alerts, six investigators inspecting, FIVE Form 483s; four product seizures, three warning letters, two U. S. Marshalls, and a copy of a consent decree.
9. On the ninth day of Christmas the FDA gave to me, nine Class I recalls, eight enforcement reports, seven MedWatch alerts, six investigators inspecting, FIVE Form 483s; four product seizures, three warning letters, two U.S. Marshalls, and a copy of a consent decree.
10. On the tenth day of Christmas the FDA gave to me, ten refusals to accept, nine Class I recalls, eight enforcement reports, seven MedWatch alerts, six investigators inspecting, FIVE Form 483s; four product seizures, three warning letters, two U.S. Marshalls, and a copy of a consent decree.
11. On the eleventh day of Christmas the FDA gave to me, eleven MDRs, ten refusals to accept, nine Class I recalls, eight enforcement reports, seven MedWatch alerts, six investigators inspecting, FIVE Form 483s; four product seizures, three warning letters, two U. S. Marshalls and a copy of a consent decree.
12. On the twelfth day of Christmas the FDA gave to me, twelve days to pay the establishment registration fee, eleven MDRs, ten refusals to accept, nine Class I recalls, eight enforcement reports, seven MedWatch alerts, six investigators inspecting, FIVE Form 483s; four product seizures, three warning letters, two U. S. Marshalls and a copy of a consent decree.

Takeaways

Dr. D’s only takeaway from this week’s guidance is the doctor hopes you had as much fun reading this week’s guidance as Dr. D had writing it! Please enjoy the holiday season with your families. For those readers celebrating Christmas, Merry Christmas from Dr. D! In closing, thank you again for joining Dr. D, and I hope you find value, or should the doctor say, enjoyment in the guidance provided. Until the next installment of DG, cheers from Dr. D. and best wishes for continued professional success.