Melanie W. Pishnery
FDA investigator
Appears on 4 documents from 2022 to 2025, mostly at sites in Japan. Most often cites design and construction features (21 CFR 211.42(c)(10)).
- 4
- Documents on file
- 3.8
- Observations per 483
- 2022
- First seen
- 2025
- Most recent
What they cite most
From 15 observations- 21 CFR 211.42(c)(10)Design and construction features2
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 211.110(b)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
Activity by year
2022: 1, 2023: 2, 2025: 1
Where
Japan 2 · Georgia 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-02-13 | 483 Tristel Solutions LimitedFeb 13, 2025 | — | 3 | |
| 2023-03-30 | 483 Terumo Yamaguchi CorporationMar 30, 2023 · Yamaguchi, Japan | Yamaguchi, Japan | 2 | |
| 2023-03-21 | 483 TERUMO CORPORATIONMar 21, 2023 · SHOWACHO, Japan | SHOWACHO, Japan | 8 | |
| 2022-03-18 | Amended 483 Pajunk Medical Systems, L.P.Mar 18, 2022 · Alpharetta, Georgia | Alpharetta, Georgia | 2 |
About this profile
What does Melanie W. Pishnery inspect?
Melanie W. Pishnery appears on 4 documents on file covering 3 sites, mostly in Japan.
What do they cite most often?
21 CFR 211.42(c)(10) (design and construction features), followed by 21 CFR 211.68(b) and 21 CFR 820.90(a).
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 Melanie W. Pishnery is dated Feb 13, 2025.