# FDA 483 - Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services - April 15, 2021

Source: https://www.globalkeysolutions.net/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/abff9fe5-5b8a-4081-8e5f-ca3fbaf38379

> FDA 483 for Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services on April 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services
- Inspection Date: 2021-04-15
- 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, revealed significant deficiencies in manufacturing process control and quality system documentation. Observations included inadequate control over the vial capping process, a lack of requalification for critical worst-case equipment, and a deficient standard operating procedure for aseptic process validation. These issues indicate a need for improved control over manufacturing operations and updated procedural guidelines.

## Related Documents

- [483 - 2014-01-29](https://www.globalkeysolutions.net/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/ea44ca0c-3122-4c5f-99ca-2a21474a70b0)
- [483 - 2018-12-07](https://www.globalkeysolutions.net/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/94fbf236-bfa7-48b8-963a-791efec4a0d9)
- [483 - 2020-11-05](https://www.globalkeysolutions.net/records/483/lyophilization-services-of-new-england-inc-lsne-dba-pci-pharma-services/c96df70e-fb11-4e22-b6de-43a29e472416)
- [483 - 2023-09-27](https://www.globalkeysolutions.net/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.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

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