Valisure in the hot seat: New Form 483 over a 2021 inspection as CEO fires back
The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.
The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of drug supply chain security requirements.
During an inspection last year, investigators had looked at records related to four “lots” of product that were in its possession, including records, testing results and more. FDA investigators observed that the company had failed to investigate suspect product and make “determinations of illegitimate product” in coordination with the manufacturer.
In an email to Endpoints News, Valisure CEO David Light emphasized:
Quick summary is that FDA inspectors came to Valisure in May 2021 for a 6-week inspection over their apparent concern that we were performing GMP testing which we do not, and they produced no evidence suggesting that we were and over DSCSA which did not apply to us even at the time of inspection because we had sold our pharmacy. The inspection resulted in a 483 that outlined a series of violations that are either pharmacy-related and therefore unrelated to our current operations or indicative of a fundamental misunderstanding of Valisure’s business which offers independent certification and testing services that are purposely not GMP.
Further inspection by the FDA observed that ValisureRx did not have systems in place to ensure compliance with certain “verification requirements” and that Valisure had never filed an annual report with the FDA. However, the US regulator notes that since the sale of its distribution arm, Valisure is not a licensed dispenser and that Valisure was not engaged in wholesale distribution activities at the time of inspection.
“We also are concerned that your distributor and pharmacy clients, despite not being obligated to perform the same type of release testing required of finished dosage form manufacturers under CGMP, may rely on your testing while a drug is held for sale, to inform their decision to further place a drug into interstate commerce,” the letter said.
The FDA noted in the letter that it was concerned that “manufacturers may rely on your services in the future to perform contract testing to fulfill CGMP requirements.”
The letter noted “methodological deficiencies” that were found upon the FDA’s inspection, including Valisure not demonstrating the analytical methods used to generate certificates of analysis, not properly addressing out-of-specification test results, using analytical instruments that were not qualified for the testing being performed and not having the correct control over analytical data.
While the FDA is concerned that Valisure will use test results for cGMP purposes, the company now has around 30 days to respond to the FDA to address the concerns.
Light said that cGMP testing is designed to be “product formulation-specific validation,” whereas Valisure specifically designs its test to be “broad screens” that can identify critical issues.
“Certainly, Valisure’s highly impactful discoveries and studies in the last few years strongly demonstrate how important it is to employ independent testing/screening in addition to GMP testing/validation and that the two are not the same but complementary and much needed for protecting public health,” Light told Endpoints.
Overall Valisure and Light emphasize that the company does not plan to conduct or offer any form of cGMP testing and will plan to respond to the FDA within the time period.
Valisure has been at the center of several FDA-related sagas, including contaminated heart burn and other pills filled with ranitidine, as well as sunscreens and shampoos. Valisure was also in the news this week as a federal judge dismissed claims that the once top-selling heartburn medication Zantac causes cancer.