FDA Inspection
LGM Pharma Solutions, LLCLGM Pharma Solutions, LLC – FDA Inspection, Aug 17, 2018
Record Details
This FDA Inspection record concerns LGM Pharma Solutions, LLC, with an inspection on August 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Angela Shepas (Company Rep)
- Richard A. Abate (Issuing Officer)
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ID · ca7148c1-4596-4434-a574-793ec136f744
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062404
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(g)(1)Failure to submit electronic format safety report
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
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Other FDA inspections of LGM Pharma Solutions, LLC
13| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| January 24, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 1, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 31, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 20, 2017 | Not classified | Los Angeles District Office | Generic Drug Evaluation |
Other documents for LGM Pharma Solutions, LLC
- FDA Inspection 1317740 - 2026-05-18
- FDA Inspection 1232056 - 2025-01-24
- FDA Inspection 1230374 - 2024-03-01
- FDA Inspection 1120565 - 2020-01-31
- FDA Inspection 1029466 - 2017-10-20
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