Yesterday US Food and Drug Administration (FDA) warning letters came back, and they indicate the agency’s actions on novel and critical public health risks. The recent federal government shutdown appeared to slow the weekly issuance of FDA warning letters. I am glad these inspections and enforcement actions have recommenced. Read below for a few highlights.
A reproductive health clinic (i.e. fertility clinic) in Miami received a warning for failures in screening for Zika virus and other infectious diseases. Inspectors noted inadequate labeling of specimens (including semen). In addition, the clinic gave some donors an “eligible” approval before receiving the results of infectious disease testing.
There is also a worrying observation about issues at the clinic that go back four years, to 2015:
In response to Observations 3 and 4, you stated that your corrective action was to review and sign the appropriate forms in a timely manner based on the results of donor screening and testing. However, we note that these two observations were also cited during the previous inspection of your establishment conducted from November 19, 2015 to December 2, 2015. Your corrective actions, if any, after the previous inspection were not adequate to prevent recurrence of the same violations, as they were cited again during the current inspection.
Reading this letter I get the impression that basic laboratory controls are missing. This is unfortunate especially since the clinic is affiliated with a university. The letter mentioned Zika virus, west Nile virus, and a prion disorder called Creutzfeldt-Jakob disease. I sometimes wonder if we are failing to learn the required lessons from these emerging diseases. A few years on from the worst of the Zika outbreak, we still have inadequate screening and testing, even in a high-risk region such as south Florida.
The FDA warned an online store for vaping juice and devices after the store sold these nicotine products to a minor.
If you are curious about vaping and teenagers, check out this recent New York Times article that paints a sad portrait of addicted kids. It also cites a statistic that “3.6 million middle and high school students are now vaping regularly.” I happen to believe that a teenager is better off vaping than smoking. However the addictive potential and long-term health risks of vaping are unknown. In addition the kids can vape anywhere, they can easily conceal these small devices, and they have no clear path to quitting.
It is in this context that the FDA has warned this and other companies that sell electronic nicotine delivery system (ENDS) products. Get used to that ENDS acronym because vaping is an issue that will not go away any time soon.
Also, I have to point out the cake, candy and fruit-flavored nicotine e-juice this company is selling. Some of them are even in a fruit juice box-style packaging! It’s hard to deny that they are marketing to kids:
Imported over-the-counter drugs
A manufacturer in China was cited for producing over-the-counter drugs (which are sold in the US) in the same equipment as non-drug products. This practice is unacceptable under the Good Manufacturing Practice (GMP) regulations.
The inspector cited other ongoing violations, including inadequate stability-indicating methods on the drugs and distributing drug batches without the quality unit’s review of failing test results. Interestingly, the company’s previous response was deemed inadequate because it did not include a root cause analysis. To me this shows the importance of thorough investigations when a failure occurs.
Pest-ridden food distributors
This one is gross. At a food storage and distribution facility in Florida, an inspector observed:
· One live cockroach on the wall along the east side of your freezer, under racking storing various food products.
· Three dead cockroaches in between packages of “United Sugars, Extra Fine Granulated, Pure Sugar Cane” packaged in 5lb paper bags. These packages were on a pallet along the wall on the west storage area, near the north end of the facility.
· An apparent birds’ nest along the ceiling in a center aisle, in the east storage area, across from the freezer and cooler.
· Apparent bird excreta on several boxes of “Loty Chicken Flavor Bouillon,” which were stored on a pallet near the wall shared with the south end of the freezer.
· Five dead cockroaches in Cooler #1 along the wall on both sides of the door. This cooler is used to store rice and other products which require a cool environment.
· Apparent cockroach parts (e.g., wings and exoskeleton parts) too numerous to count throughout your facility, along the east and center aisles in between racking systems, and along the walls.
· A powder, identified by your firm as a mix of corn flour and ground-up rodent bait blocks, throughout your entire facility along the walls, and in between racking systems of stored packaged food products. The bait was identified to be “Bell Contrac All Weather Blox” used to kill rats, mice and meadow voles.
· Your three dock doors used for shipping and receiving along the north end of the facility are open during business hours and are not screened to exclude any type of rodent or pest from entering the facility.
I appreciate the inspector’s thoroughness! They counted the roaches, poop and other animal signs, and noted their location. An audit finding should always be specific so that a follow-up inspection can verify whether corrective actions were effective.
Another food processing facility in Florida was warned over a repeated failure to follow a specific pathogen reduction process in their fruit juices. Because of the repeated nature of the violations, the letter included an interesting note about how the FDA is authorized “to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.”
If they have to keep coming back to help you get your act together, you might have to pay!
FDA warning letters are a treasure trove of information to help you understand the agency’s enforcement priorities on a wide array of medical and consumer products. I think it’s just a coincidence that three of the five entities cited here are in Florida.
The FDA website noted early on in the shutdown that “agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.” I am not sure if this included the inspections referenced in this letter. However, I wouldn’t be surprised if there is a gap in warning letter postings three to six months from now.
The letter to the fertility clinic highlights a real risk: what if you or your fetus contracted the Zika virus from an anonymous sperm donor? For its part the underage vaping issue is big and it will only get bigger. The only apparent requirement for getting this nicotine vape juice from the site above is a credit card and a mailing address. The over-the-counter drugs could be part of a recall if the company’s response is deemed inadequate. This means American consumers could have to search their medicine cabinets for the bad pills. Finally, the pest issues at the food facilities are just gross.
Centers for Disease Control and Prevention:
“No instances of Zika virus transmission during fertility treatment have been documented, but transmission through donated gametes or embryos is theoretically possible.”
Recently Posted Warning Letters
New York Times:
“Addicted to Vaped Nicotine, Teenagers Have No Clear Path to Quitting”
Check out these kid-friendly nicotine vaping juices