# FDA 483 - CooperSurgical, Inc. - February 01, 2024

Source: https://www.keypedia.com/records/483/coopersurgical-inc/ed2f72a5-6ccf-4fd9-8ae4-643726bf5d62

> FDA 483 for CooperSurgical, Inc. on February 01, 2024. Product: devices. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CooperSurgical, Inc.
- Inspection Date: 2024-02-01
- Product Type: devices
- Office Name: New York District Office
- Summary: The FDA conducted an inspection of CooperSurgical, Inc., a manufacturer of drug/medical device combination products, from January 29 to February 1, 2024, at their North Tonawanda, NY facility. The inspection revealed significant observations regarding the company's quality system, documented in a Form FDA 483.

The primary issues identified relate to the inadequate establishment and execution of procedures for corrective and preventive actions (CAPA). Specifically, a review of CAPAs found that many lacked sufficient investigation, and several remained open for extended periods without adequate verification of corrective action effectiveness. A key procedural deficiency was the absence of a requirement to verify that corrective actions do not adversely impact finished products. Furthermore, an internal audit in late 2022 uncovered quality system discrepancies, including failures to address previous inspection findings, yet a formal CAPA was not initiated to investigate these issues or confirm the efficacy of subsequent system updates.

Additionally, the inspection highlighted inadequate validation of a critical manufacturing process. The validation of the pouch sealing process for the Paragard T 380A intrauterine copper contraceptive lacked a statistical rationale for its sample size. There was also insufficient documentation to justify the sample size used in validation runs when compared to the facility's approximate annual production volume.

CooperSurgical, Inc. is required to formally respond to these observations by outlining comprehensive corrective actions to address each deficiency and ensure full compliance with regulatory standards for quality systems and process validation.

## Related Documents

- [483 - 2022-03-04](https://www.keypedia.com/records/483/coopersurgical-inc/cae64b1c-d57c-4a99-9abb-291ea0fb2e32)
- [483 - 2024-02-01](https://www.keypedia.com/records/483/coopersurgical-inc/b95fba02-cef5-4e8c-a8d7-e19e31e5a0dd)

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/coopersurgical-inc/e8101a6e-759d-4f9c-93ab-17527ba3e477

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d