FDA Inspection
LGM Pharma Solutions, LLCLGM Pharma Solutions, LLC – FDA Inspection, Oct 20, 2017
Record Details
This FDA Inspection record concerns LGM Pharma Solutions, LLC, with an inspection on October 20, 2017, issued by the Los Angeles District Office, covering human drugs.
- People
- Bryan A. Galvez (FDA Associated Person)
- Christopher D. Washington (Issuing Officer)
- Truong X. Nguyen (FDA Associated Person)
- Vioela Respress (Issuing Officer)
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ID · bec6dcf5-e6db-4838-a7c9-aa6757434988
Inspection Facts
- Inspection number
- 1029466
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.130(e)Packaging line inspection documentation
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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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 |
| August 17, 2018 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
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 1062404 - 2018-08-17
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