FDA Inspection
Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma ServicesLyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services – FDA Inspection, May 24, 2024
Record Details
This FDA Inspection record concerns Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services, with an inspection on May 24, 2024, issued by the Center for Drug Evaluation and Research.
- Inspection Date
- May 24, 2024
View Company Profile
ID · 66bf6291-43c6-4007-aa3a-035315260b2e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239754
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
FDA Citations
5- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2026 | Not classified | New England District Office | Drug Quality Assurance |
| September 27, 2023 | OAI | New England District Office | |
| December 7, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services
- FDA Inspection 1321518 - 2026-06-10
- FDA Inspection 1218916 - 2023-09-27
- FDA Inspection 1074079 - 2018-12-07
- FDA Inspection 1003136 - 2017-02-15
- FDA Inspection 1002975 - 2017-02-15
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