# FDA 483 - Emerson Hospital - February 04, 2019

Source: https://www.keypedia.com/records/483/emerson-hospital/e867c1ea-2888-432a-8357-70b434cdff14

> FDA 483 for Emerson Hospital on February 04, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emerson Hospital
- Inspection Date: 2019-02-04
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: Emerson Hospital, a blood bank establishment in Concord, MA, was cited for failing to assign dating periods for irradiated red blood cell units in accordance with regulations. Specifically, the firm assigned expiration dates exceeding 28 days from the date of irradiation for 16 units. This indicates a lapse in compliance with established dating period requirements.

## Related Officers

- [Investigator](https://www.keypedia.com/people/alice-silva/b4b46db5-2b1a-452c-a403-9265a8785330)

Company: https://www.keypedia.com/companies/emerson-hospital/f5210e72-6185-4844-a510-2da4585f63ac

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