Richard Ledwidge
FDA investigator · also recorded as Aa Lu Richard Ledwidge, Pie An Richard Ledwidge
Appears on 18 documents from 2015 to 2024, most often at sites in India. Most often cites control of microbiological contamination (21 CFR 211.113).
- 18
- Documents on file
- 5.4
- Observations per 483
- 2015
- First seen
- 2024
- Most recent
What they cite most
From 97 observations- 21 CFR 211.113Control of microbiological contamination14
- 21 CFR 211.192Production record review11
- 21 CFR 211.160General requirements10
- 21 CFR 211.67Equipment cleaning and maintenance8
- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.42Design and construction features7
Activity by year
2015: 1, 2017: 1, 2018: 2, 2019: 1, 2021: 1, 2022: 5, 2023: 4, 2024: 3
Where
India 2 · Ireland 2 · Italy 2 · Austria 1 · California 1 · China 1
Often inspects with
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Inspection history
18 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-11-12 | 483 FUJIFILM Diosynth Biotechnologies Denmark ApSNov 12, 2024 · Hillerod, Denmark | Hillerod, Denmark | 3 | |
| 2024-07-26 | 483 Biocon Biologics LimitedJul 26, 2024 · Bengalurn, India | Bengalurn, India | 10 | |
| 2024-04-30 | 483 CSL Behring GmbHApr 30, 2024 · Marburg, Germany | Marburg, Germany | 7 | |
| 2023-12-15 | 483 Suzhou Suncadia Biopharmaceuticals Co., Ltd.Dec 15, 2023 · Suzhou, China | Suzhou, China | 10 | |
| 2023-05-22 | 483 Sanofi S.p.AMay 22, 2023 · Anagni, Italy | Anagni, Italy | 2 | |
| 2023-05-10 | 483 MERCK SERONO SPAMay 10, 2023 · Bari, Italy | Bari, Italy | 5 | |
| 2023-03-17 | 483 Alvotech HfMar 17, 2023 · Reykjavik, Iceland | Reykjavik, Iceland | 8 |
About this profile
What does Richard Ledwidge inspect?
Richard Ledwidge appears on 18 documents on file covering 17 sites, most often in India.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 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 Richard Ledwidge is dated Nov 12, 2024.