Holly Sheffield
President
CooperSurgical, Inc.
75 Corporate Drive
Trumbull , CT 06611
United StatesFEI 1216677Issued Feb 12, 2021The Office of Prescription Drug Promotion (OPDP)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1216677.
Violations2
Issue DateFeb 12, 2021
Product TypeDrugs
StatusClosed
Closeout LetterJun 22, 2022
Letter Details
Firm
CooperSurgical, Inc.
Location
Holly Sheffield
President
CooperSurgical, Inc.
75 Corporate Drive
Trumbull , CT 06611
United States
FEI Number
1216677
Country
United States
Issue Date
February 12, 2021
Issuing Office
The Office of Prescription Drug Promotion (OPDP)
Product Type
Drugs
Status
Closed
Closeout Letter
June 22, 2022
Summary
CooperSurgical distributed a direct-to-consumer video promoting Paragard (intrauterine copper contraceptive) that presented efficacy claims while failing to include any risk information, thereby misbranding the drug in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to submit the promotional video for FDA review at the time of initial dissemination as required by regulations. The FDA found these violations concerning from a public health perspective because the promotional communication created a misleading impression about Paragard's safety profile.
CooperSurgical, Inc. FDA Warning Letter, February 12, 2021
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