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, Jun 10, 2026
Record Details
This FDA Inspection record concerns Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services, with an inspection on June 10, 2026, issued by the New England District Office, covering human drugs.
- Inspection Date
- June 10, 2026
- Product Type
- Human Drugs
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ID · 98be2869-e2d8-4d6d-8f31-f8b092a80149
Inspection Facts
- Inspection number
- 1321518
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2024 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| 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 1239754 - 2024-05-24
- 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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