The foundation that operates Shell Point Retirement Community said it self-reported a deficiency in controlled substances inventory at the Lee County facility in 2021, relinquished its DEA certification and agreed to pay a $250,000 fine.
The Christian & Missionary Alliance Foundation, Inc. of Fort Myers agreed to the fine to resolve allegations that the Foundation violated the Controlled Substances Act by failing to maintain records required by the act.
The United States alleges that on July 14, 2021, the Drug Enforcement Administration (DEA) initiated an inspection of the Foundation facility, at 15051 Shell Point Boulevard, and determined that it committed 176 violations of the CSA, including failing to take a new inventory of all controlled substances on hand at least once every two years, failing to maintain records of the number of units acquired from other persons, and failing to notify the DEA of a theft or loss within one business day of the discovery.
The Shell Point Retirement Communityon Shellpoint Boulevard in Lee County was founded as a nonprofit ministry in 1968 by The Christian & Missionary Alliance denomination.
The Foundation released a statement Monday afternoon:
“In December of 2021, through internal processes, The Christian & Missionary Alliance Foundation learned of pharmacy record-keeping deficiencies. Upon self-reporting to the Drug Enforcement Administration, an investigation occurred and fines were assessed as is normal course," the statement said. "Due to the complexity of regulatory compliance, the Foundation chose to outsource pharmacy services and subsequently returned its DEA registration (on February 4, 2022). The organization cooperated fully, and the matter was resolved without any determination of liability. The Foundation remains committed to maintaining the highest standards of compliance and integrity in all operations.”
U.S. Attorney Roger Handberg said that scrupulous recordkeeping is essential to maintaining the CSA’s closed system of distribution and preventing dangerous drugs from falling into the wrong hands.
“We expect all DEA registrants, no matter their size, to be especially meticulous in their recordkeeping because the CSA and the welfare of the public demand it,” Handberg said.
“DEA Registrants are obligated to comply with the regulations set forth in the Controlled Substances Act, ensuring accurate inventorying, tracking and recordkeeping, as the failure to do so can lead to the diversion of controlled substances, which jeopardizes the safety and health of our communities,” said DEA Miami Field Division Special Agent in Charge Deanne L. Reuter. “DEA remains committed to working with our law enforcement and regulatory partners to hold registrants accountable and ensure these regulations are followed.”
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