Song Y. Lavalais
FDA investigator
Appears on 5 documents from 2021 to 2023, most often at sites in Georgia. Most often cites control of microbiological contamination (21 CFR 211.113).
- 5
- Documents on file
- 6.4
- Observations per 483
- 2021
- First seen
- 2023
- Most recent
What they cite most
From 32 observations- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.192Production record review2
- 21 CFR 211.25Personnel qualifications2
Activity by year
2021: 2, 2022: 2, 2023: 1
Where
Georgia 2 · North Carolina 2 · South Carolina 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-02-10 | 483 Nephron Sterile Compounding Center LLCFeb 10, 2023 · West Columbia, South Carolina | West Columbia, South Carolina | 15 | |
| 2022-08-26 | 483 Biogen U.S. CorporationAug 26, 2022 · Morrisville, North Carolina | Morrisville, North Carolina | 1 | |
| 2022-03-11 | 483 Family Pharmacy of Statesville, IncMar 11, 2022 · Statesville, North Carolina | Statesville, North Carolina | 9 | |
| 2021-09-17 | 483 Acella Pharmaceuticals, LLCSep 17, 2021 · Alpharetta, Georgia | Alpharetta, Georgia | 5 | |
| 2021-08-09 | 483 HomeChoice Partners dba BioScrip Infusion ServicesAug 9, 2021 · Augusta, Georgia | Augusta, Georgia | 2 |
About this profile
What does Song Y. Lavalais inspect?
Song Y. Lavalais appears on 5 documents on file covering 5 sites, most often in Georgia.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.42 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 Song Y. Lavalais is dated Feb 10, 2023.