Marjorie A. Shapiro
FDA investigator
Appears on 2 documents from 2017 to 2018, mostly at sites in Austria. Most often cites control of microbiological contamination (21 CFR 211.113).
- 2
- Documents on file
- 5.5
- Observations per 483
- 2017
- First seen
- 2018
- Most recent
What they cite most
From 11 observations- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.111Time limitations on production1
Activity by year
2017: 1, 2018: 1
Where
Austria 1 · New York 1
Often inspects with
Is Marjorie A. Shapiro coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-02-20 | 483 Sandoz GmbHFeb 20, 2018 · Langkampfen, Austria | Langkampfen, Austria | 4 | |
| 2017-03-17 | 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLCMar 17, 2017 · Pearl River, New York | Pearl River, New York | 7 |
About this profile
What does Marjorie A. Shapiro inspect?
Marjorie A. Shapiro appears on 2 documents on file covering 2 sites, mostly in Austria.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.160 and 21 CFR 211.67.
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 Marjorie A. Shapiro is dated Feb 20, 2018.