# FDA 483 - CooperSurgical, Inc. - March 04, 2022

Source: https://www.keypedia.com/records/483/coopersurgical-inc/cae64b1c-d57c-4a99-9abb-291ea0fb2e32

> FDA 483 for CooperSurgical, Inc. on March 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CooperSurgical, Inc.
- Inspection Date: 2022-03-04
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: CooperSurgical, Inc. in North Tonawanda, NY, a pharmaceutical drug manufacturer, received an FDA Form 483 citing significant quality control deficiencies. Observations included inadequate investigations into out-of-specification results and customer complaints, and a failure to thoroughly review manufacturing discrepancies. Additionally, the firm lacked scientifically sound laboratory controls for package seal integrity and detailed, validated cleaning and maintenance procedures for equipment.

## Related Documents

- [483 - 2024-02-01](https://www.keypedia.com/records/483/coopersurgical-inc/b95fba02-cef5-4e8c-a8d7-e19e31e5a0dd)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)
- [Syeda R Mahatabdin](https://www.keypedia.com/people/syeda-r-mahatabdin/8d9efdb4-90f9-4749-90a0-67473d647601)

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

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248