Mekonnen Lemma Dechassa
FDA investigator
Appears on 3 documents from 2019 to 2021, mostly at sites in China. Most often cites general requirements (21 CFR 211.180).
- 3
- Documents on file
- 5.0
- Observations per 483
- 2019
- First seen
- 2021
- Most recent
What they cite most
From 15 observations- 21 CFR 211.180General requirements3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.170Reserve samples2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.192Production record review1
Activity by year
2019: 1, 2020: 1, 2021: 1
Where
China 2 · South Korea 1
Often inspects with
Christopher T. Middendorf· Ramesh Potla· Madushini Dharmasena
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2021-08-20 | 483 Hugel, Inc.Aug 20, 2021 · Chuncheon, South Korea | Chuncheon, South Korea | 7 | |
| 2020-04-16 | 483 Wuxi Biologics Co LtdApr 16, 2020 · Wuxi, China | Wuxi, China | 4 | |
| 2019-04-16 | 483 WuXi Biologics Co., Ltd.Apr 16, 2019 · Wuxi, China | Wuxi, China | 4 |
About this profile
What does Mekonnen Lemma Dechassa inspect?
Mekonnen Lemma Dechassa appears on 3 documents on file covering 1 site, mostly in China.
What do they cite most often?
21 CFR 211.180 (general requirements), followed by 21 CFR 211.113 and 21 CFR 211.160.
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 Mekonnen Lemma Dechassa is dated Aug 20, 2021.