What the FDA has been looking for in their audits
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THE FDA CONSULTANTS, LLC
BY: ERIN FLYNN JAY
Last year, the FDA issued a warning letter to a New York City fertility center after an FDA investigator documented significant deviations for human cells, tissues, and cellular and tissue-based products. In 2020, the FDA issued a warning letter to a California IVF fertility center after an FDA investigator found the same issue.
In 2019, the FDA ordered a San Juan, Puerto Rico clinic and its Medical Director to cease manufacturing immediately due to significant violations of FDA regulations. An FDA inspection revealed violations regarding donor eligibility determinations. According to the FDA, the clinic put patients at risk for exposure to communicable diseases, including HIV and Hepatitis.
How does the FDA audit fertility centers? According to Rijon Charne, Fertility Attorney with Sunray Fertility and Chief Legal Officer with The FDA Consultants, the FDA performs random inspections whenever they want. The inspector arrives without notice to inspect the clinic. “They go straight into your lab, they start pulling files, and they start looking at the specimens to see if any of them violate FDA regulations under the specific code.”
Sunday Crider, PhD, HCLD/ELD (ABB), Chief Scientific Officer with The FDA Consultants, said when the FDA finds an offense during a laboratory inspection, they generate a “Form 483”, which is an official documentation of deficiencies .. “The FDA will review areas of concern with the responsible person at the clinic in a debriefing session post-inspection. The official Form 483 is then sent to the clinic within a few weeks. The laboratory will generally have 30 days to respond to the FDA on how they are going to address those deficiencies.”
Once a clinic registers with the FDA, they are subjected to routine, unannounced inspections at the Agency’s discretion. However, Crider said if serious issues are found on any laboratory inspection,, the FDA may come and inspect more frequently.. Inspection records are retained by the FDA for every registered facility. Inspections are generally on a two year rotation and almost always unannounced. FDA inspections are nerve-racking for clinics because of the repercussions if the FDA finds something. Charne spoke of issues of donor eligibility, one of the most common deficiencies the FDA discovers. There are specific labeling requirements for donors that might have HIV or a sexually transmitted infection (STI). Regarding donor oocytes, “those eggs have to be specifically labeled and they need to be put in a separate freezer so that there is no chance of possible cross-contamination with other eggs or other specimens that are being held in the lab.”
If the FDA finds there are egregious issues with donor screening, testing, labeling or storage during an inspection, they issue a public warning and post it to the FDA website. The clinic then needs to address the issue with a written plan, to be approved by the FDA. Charne said the FDA will return and either pass the lab’s inspection or shut them down.
“The worst part of it all is that the warning to the clinic becomes public,” added Charne. “The notice is put out in an FDA Warning Letter and the clinic goes on the FDA warning list. Any patient (current or potential) of the IVF clinic can see the warning letter on the FDA website. As the fertility space is such a small community and reputation is everything, when people talk, it looks very bad for the clinic.”
FDA violations and warnings can be especially harmful during mergers or acquisitions, especially for private equity firms or Management Services Organizations (MSO) that may want to sell a fertility clinic in the future. An FDA violation could affect the price valuation of the entity and create pause for an insurance company to underwrite a policy for the clinic.
“An FDA violation or warning will raise questions and concerns,” said Charne. “That is why private equity companies and law firms assisting in fertility acquisitions bring on people like the FDA Consultants to do a neutral third party inspection before getting caught in are a unknown FDA violation. The worst issue that could occur is the FDA shutting you down.”
Crider said that while the FDA is only concerned about donor issues, a warning or violation from the FDA tarnishes the reputation of the entire clinic. “You don't want it made public that you do not have good patient care and are okay putting a patient at risk,” she said.
The FDA requires clinics to maintain donor records for at least 10 years. This is to ensure traceability of donor records, such as communicable disease testing. For instance, Crider stated, if the recipient of donor eggs or sperm contracted HIV at some point in their life after receiving the donor tissue, it would be important to have records on file to show that the source likely did not come from their anonymous donor, as they are thoroughly screened and tested as a part of becoming an eligible donor. Proper documentation that the donor was thoroughly screened and tested would become critical should any patient care or legal issues arise.
Bottom line: every IVF laboratory that processes, screens, stores, tests or distributes any type of donor tissue--be it egg, sperm, or embryo--must register with the FDA and follow the Federal Code 21 CFR Part 1271, guidelines they have set forth. If not, prepare for that FDA violation.
This News Digest Story is paid featured sponsor content, where the Advertiser has editorial control. They do not reflect the views of Inside Reproductive Health.
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