# FDA 483 - Contract Manufacturing NE LLC - June 06, 2022

Source: https://www.globalkeysolutions.net/records/483/contract-manufacturing-ne-llc/76458ec4-81f5-440a-9629-0f73b6b2f2ed

> FDA 483 for Contract Manufacturing NE LLC on June 06, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contract Manufacturing NE LLC
- Inspection Date: 2022-06-06
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Contract Manufacturing NE LLC in Bristol, CT, was cited for significant violations during an FDA inspection, primarily concerning allergen control and manufacturing practices. The firm failed to prevent allergen cross-contact, leading to undeclared tree nuts in products and a Class I recall. Additionally, the company lacked proper master manufacturing records for dietary supplements and operated under unsanitary conditions, including storing in-process food directly on the ground.

## Related Officers

- [Emily J. Schramm](https://www.globalkeysolutions.net/people/emily-j-schramm/11816c39-c5c0-4adb-8d83-83f89e648850)

Company: https://www.globalkeysolutions.net/companies/contract-manufacturing-ne-llc/b283531c-1a5b-4124-ae62-f9bfc8381623

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7