Hugh M. McClure
FDA investigator
Appears on 5 documents from 2013 to 2021, most often at sites in Texas. Most often cites written procedures; deviations (21 CFR 211.100).
- 5
- Documents on file
- 4.0
- Observations per 483
- 2013
- First seen
- 2021
- Most recent
What they cite most
From 16 observations- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 312.62(a)Investigator recordkeeping and record retention2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 312.53(c)(4)Selecting investigators and monitors1
Activity by year
2013: 3, 2020: 1, 2021: 1
Where
Texas 2 · Germany 1 · Maryland 1 · Ohio 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2021-08-13 | 483 Ricerca Biosciences, LLCAug 13, 2021 · Painesville, Ohio | Painesville, Ohio | 3 | |
| 2020-02-18 | 483 Rommelag CDMO GmbHFeb 18, 2020 · Sulzbach-Laufen, Germany | Sulzbach-Laufen, Germany | 5 | |
| 2013-12-03 | Warning letter Warning letter, Dec 3, 2013Dec 3, 2013 · Houston, Texas | Houston, Texas | — | |
| 2013-03-15 | 483 Stanislaw R Burzynski, M.DMar 15, 2013 · Houston, Maryland | Houston, Maryland | 6 | |
| 2013-03-15 | 483 Burzynski Research InstituteMar 15, 2013 · Houston, Texas | Houston, Texas | 2 |
About this profile
What does Hugh M. McClure inspect?
Hugh M. McClure appears on 5 documents on file covering 4 sites, most often in Texas.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 312.62(a) and 21 CFR 211.166.
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 Hugh M. McClure is dated Aug 13, 2021.