# FDA 483 - Lyophilization Services of New England Inc. - July 31, 2013

Source: https://www.globalkeysolutions.net/records/483/lyophilization-services-of-new-england-inc/b115cbe2-63d3-476d-a14f-ab47486344dc

> FDA 483 for Lyophilization Services of New England Inc. on July 31, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lyophilization Services of New England Inc.
- Inspection Date: 2013-07-31
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Lyophilization Services of New England Inc. in Bedford, NH, a sterile product manufacturer, revealed significant deficiencies in quality control and aseptic processing. The firm failed to thoroughly investigate foreign material contamination, including black spots and protein-like particulates, in sterile drug product vials. Additional concerns included inadequate container integrity studies, deficient in-process controls, insufficient sterilization validation, and poor environmental monitoring practices in aseptic areas, indicating a high risk to product quality and sterility.

## Related Officers

- [Ramon E. Martinez](https://www.globalkeysolutions.net/people/ramon-e-martinez/9d3b4ce9-a11e-4c47-9e53-a5732ac13bdf)

Company: https://www.globalkeysolutions.net/companies/lyophilization-services-of-new-england-inc/f8f883b4-fa88-4915-bad0-8f2c414498ab

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