Libia M. Lugo
FDA investigator
Appears on 24 documents from 2013 to 2024, mostly at sites in Puerto Rico. Most often cites production record review (21 CFR 211.192).
- 24
- Documents on file
- 3.9
- Observations per 483
- 2013
- First seen
- 2024
- Most recent
What they cite most
From 91 observations- 21 CFR 211.192Production record review16
- 21 CFR 211.160General requirements10
- 21 CFR 211.22Responsibilities of quality control unit10
- 21 CFR 211.113Control of microbiological contamination9
- 21 CFR 211.165Testing and release for distribution7
- 21 CFR 211.100Written procedures; deviations6
Activity by year
2013: 2, 2015: 3, 2016: 1, 2017: 2, 2018: 2, 2019: 6, 2022: 2, 2023: 3, 2024: 3
Where
Puerto Rico 14 · Florida 5 · North Carolina 3 · South Carolina 1 · United Kingdom 1
Often inspects with
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Inspection history
24 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-05-29 | 483 Olympia Compounding PharmacyMay 29, 2024 · Orlando, Florida | Orlando, Florida | 7 | |
| 2024-04-18 | 483 Knoll LLCApr 18, 2024 · Jayuya, Puerto Rico | Jayuya, Puerto Rico | 2 | |
| 2024-02-09 | Amended 483 Baxter Healthcare CorporationFeb 9, 2024 · Marion, North Carolina | Marion, North Carolina | 7 | |
| 2023-07-28 | 483 King Bio IncJul 28, 2023 · Asheville, North Carolina | Asheville, North Carolina | 2 | |
| 2023-03-17 | 483 FUJIFILM Diosynth Biotechnologies UK LtdMar 17, 2023 · Billingham, United Kingdom | Billingham, United Kingdom | 1 | |
| 2023-02-09 | 483 Ambiopharm, Inc.Feb 9, 2023 · North Augusta, South Carolina | North Augusta, South Carolina | 2 | |
| 2022-11-23 | 483 Teva Puerto Rico LLCNov 23, 2022 · Fajardo, Puerto Rico | Fajardo, Puerto Rico | 2 |
About this profile
What does Libia M. Lugo inspect?
Libia M. Lugo appears on 24 documents on file covering 21 sites, mostly in Puerto Rico.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.160 and 21 CFR 211.22.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Libia M. Lugo is dated May 29, 2024.