# FDA 483 - Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services - November 05, 2020

Source: https://www.keypedia.com/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/c96df70e-fb11-4e22-b6de-43a29e472416

> FDA 483 for Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services on November 05, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services
- Inspection Date: 2020-11-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Lyophilization Services of New England, Inc. in Bedford, NH, a drug product manufacturer, identified two observations. The inspection found that the non-aseptic manufacturing facility was not adequately maintained, with issues such as deteriorated sealant, unseated light fixtures, and chipping paint. Additionally, a standard operating procedure for manual cleaning of process equipment was deemed inadequate as it did not accurately reflect common manufacturing practices.

## Related Documents

- [483 - 2014-01-29](https://www.keypedia.com/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/ea44ca0c-3122-4c5f-99ca-2a21474a70b0)
- [483 - 2018-12-07](https://www.keypedia.com/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/94fbf236-bfa7-48b8-963a-791efec4a0d9)
- [483 - 2021-04-15](https://www.keypedia.com/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/abff9fe5-5b8a-4081-8e5f-ca3fbaf38379)
- [483 - 2023-09-27](https://www.keypedia.com/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/75c9f173-aa20-48af-801d-0567bd3f361b)

## Related Officers

- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/a2a924d8-594c-4f2a-a998-5cbd4c06c983

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd