Malgorzata G. Norton
FDA investigator
Appears on 3 documents from 2018 to 2022, most often at sites in California. Most often cites design and construction features (21 CFR 211.42).
- 3
- Documents on file
- 8.0
- Observations per 483
- 2018
- First seen
- 2022
- Most recent
What they cite most
From 24 observations- 21 CFR 211.42Design and construction features3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.101Charge-in of components1
Activity by year
2018: 1, 2019: 1, 2022: 1
Where
California 1 · France 1 · Maryland 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-12-06 | 483 Form 483 · FEI 3010600159Dec 6, 2022 · Lingolsheim, France | Lingolsheim, France | 10 | |
| 2019-09-12 | 483 Grifols Biologicals LLCSep 12, 2019 · City of Industry, California | City of Industry, California | 6 | |
| 2018-06-13 | 483 Bora Pharmaceuticals Injectables Inc.Jun 13, 2018 · Baltimore, Maryland | Baltimore, Maryland | 8 |
About this profile
What does Malgorzata G. Norton inspect?
Malgorzata G. Norton appears on 3 documents on file covering 3 sites, most often in California.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.100 and 21 CFR 211.113.
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 Malgorzata G. Norton is dated Dec 6, 2022.