Madushini Dhannasena
FDA investigator
Appears on 1 document from 2018, mostly at sites in New Jersey. Most often cites production record review (21 CFR 211.192).
- 1
- Documents on file
- 4.0
- Observations per 483
- 2018
- First seen
- 2018
- Most recent
What they cite most
From 4 observations- 21 CFR 211.192Production record review2
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
Activity by year
2018: 1
Where
New Jersey 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-08-14 | 483 Immunomedics, Inc.Aug 14, 2018 · Morris Plains, New Jersey | Morris Plains, New Jersey | 4 |
About this profile
What does Madushini Dhannasena inspect?
Madushini Dhannasena appears on 1 document on file covering 1 site, mostly in New Jersey.
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 Madushini Dhannasena is dated Aug 14, 2018.