David J. Gomes
FDA investigator · also recorded as Of Aus David Gomes
Appears on 3 documents from 2017 to 2023, most often at sites in Italy. Most often cites production record review (21 CFR 211.192).
- 3
- Documents on file
- 2.5
- Observations per 483
- 2017
- First seen
- 2023
- Most recent
What they cite most
From 8 observations- 21 CFR 211.192Production record review3
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.188Batch production and control records1
Activity by year
2017: 1, 2019: 1, 2023: 1
Where
Italy 1 · Japan 1 · Taiwan 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-11-06 | 483 Takeda Pharmaceutical Company Limi t edNov 6, 2023 · Hikari, Japan | Hikari, Japan | 4 | |
| 2019-06-20 | 483 UBI Pharma Inc.Jun 20, 2019 · Hukou, Taiwan | Hukou, Taiwan | — | |
| 2017-04-20 | 483 Wyeth Lederle S.r.lApr 20, 2017 · Catania, Italy | Catania, Italy | 1 |
About this profile
What does David J. Gomes inspect?
David J. Gomes appears on 3 documents on file covering 3 sites, most often in Italy.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.194 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 David J. Gomes is dated Nov 6, 2023.