Santiago Gallardo Johnson
FDA investigator
Appears on 18 documents from 2017 to 2023, mostly at sites in California. Most often cites production record review (21 CFR 211.192).
- 18
- Documents on file
- 3.4
- Observations per 483
- 2017
- First seen
- 2023
- Most recent
What they cite most
From 62 observations- 21 CFR 211.192Production record review10
- 21 CFR 211.22Responsibilities of quality control unit6
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
- 21 CFR 211.113Control of microbiological contamination4
Activity by year
2017: 2, 2018: 1, 2019: 6, 2020: 1, 2021: 3, 2022: 4, 2023: 1
Where
California 14 · Japan 3 · Colorado 1
Often inspects with
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Inspection history
18 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-01-25 | 483 Societal CDMO San Diego, LLCJan 25, 2023 · San Diego, California | San Diego, California | 3 | |
| 2022-11-29 | 483 Hyland's Consumer Health Inc.Nov 29, 2022 · Los Angeles, California | Los Angeles, California | 5 | |
| 2022-09-16 | 483 Daito Pharmaceutical Co., LtdSep 16, 2022 · Toyama-City, Japan | Toyama-City, Japan | 2 | |
| 2022-09-09 | 483 Ishihara Sangyo Kaisha, Ltd.Sep 9, 2022 · Yokkaichi, Japan | Yokkaichi, Japan | 2 | |
| 2022-09-02 | 483 Meiji Seika Pharma Co., Ltd. 2890 Kitagata, Kitagata-Cho, Motosa-GunSep 2, 2022 · Gifa, Japan | Gifa, Japan | 3 | |
| 2021-08-20 | 483 Teva Parenteral Medicines, Inc.Aug 20, 2021 · Irvine, California | Irvine, California | 10 | |
| 2021-05-25 | 483 Ajinomoto Althea, Inc.May 25, 2021 · San Diego, California | San Diego, California | 3 |
About this profile
What does Santiago Gallardo Johnson inspect?
Santiago Gallardo Johnson appears on 18 documents on file covering 15 sites, mostly in California.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.22 and 21 CFR 211.42.
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 Santiago Gallardo Johnson is dated Jan 25, 2023.