Deborah Schmiel
FDA investigator
Appears on 5 documents from 2016 to 2024, most often at sites in South Korea. Most often cites control of microbiological contamination (21 CFR 211.113).
- 5
- Documents on file
- 5.4
- Observations per 483
- 2016
- First seen
- 2024
- Most recent
What they cite most
From 26 observations- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.192Production record review4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.160General requirements3
- 21 CFR 211.111Time limitations on production2
- 21 CFR 211.25Personnel qualifications2
Activity by year
2016: 1, 2018: 2, 2019: 1, 2024: 1
Where
South Korea 2 · Austria 1 · Denmark 1 · Italy 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-02-29 | 483 BSP Pharmaceuticals SpAFeb 29, 2024 · Latina Scalo, Italy | Latina Scalo, Italy | 2 | |
| 2019-10-11 | 483 FUJIFILM Diosynth Biotechnologies Denmark ApSOct 11, 2019 · Hillerod, Denmark | Hillerod, Denmark | 5 | |
| 2018-06-26 | 483 Samsung Biologics Co., Ltd.Jun 26, 2018 · Incheon, South Korea | Incheon, South Korea | 3 | |
| 2018-02-20 | 483 Sandoz GmbHFeb 20, 2018 · Langkampfen, Austria | Langkampfen, Austria | 4 | |
| 2016-06-22 | 483 Samsung Biologics Co., Ltd.Jun 22, 2016 · Incheon, South Korea | Incheon, South Korea | 13 |
About this profile
What does Deborah Schmiel inspect?
Deborah Schmiel appears on 5 documents on file covering 4 sites, most often in South Korea.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.68.
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 Deborah Schmiel is dated Feb 29, 2024.