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, Dec 7, 2018
Record Details
This FDA Inspection record concerns Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services, with an inspection on December 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 7, 2018
- Product Type
- Drugs
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ID · 7c538adf-a0b1-4e0a-b885-7258322245ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074079
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
|---|---|---|---|
| June 10, 2026 | Not classified | New England District Office | Drug Quality Assurance |
| May 24, 2024 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| September 27, 2023 | OAI | New England District Office | |
| 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 1239754 - 2024-05-24
- FDA Inspection 1218916 - 2023-09-27
- FDA Inspection 1003136 - 2017-02-15
- FDA Inspection 1002975 - 2017-02-15
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