# FDA 483 - McNeil Healthcare, LLC - October 24, 2019

Source: https://www.keypedia.com/records/483/mcneil-healthcare-llc/e89ea588-cd89-43f2-9434-afa7ff142559

> FDA 483 for McNeil Healthcare, LLC on October 24, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McNeil Healthcare, LLC
- Inspection Date: 2019-10-24
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of McNeil Healthcare, Inc. in West Haven, CT, a surgical drape contract manufacturer/repacker, revealed inadequate procedures for equipment calibration and maintenance. Specifically, the firm failed to ensure equipment was calibrated to traceable standards, document calibration instruments, and verify the weight blocks used for calibration.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-g-mayfield/ec045e12-d940-4f76-a17f-98ba4a8dd5b9)

Company: https://www.keypedia.com/companies/mcneil-healthcare-llc/0e851103-e3f5-4c43-9e7e-4fd4caee4c50

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94