Rumany C. Penn
FDA investigator · also recorded as Pais Rumany C. Penn
Appears on 21 documents from 2016 to 2022, most often at sites in California. Most often cites design and construction features (21 CFR 211.42).
- 21
- Documents on file
- 4.2
- Observations per 483
- 2016
- First seen
- 2022
- Most recent
What they cite most
From 89 observations- 21 CFR 211.42Design and construction features11
- 21 CFR 211.113Control of microbiological contamination10
- 21 CFR 211.192Production record review10
- 21 CFR 211.67Equipment cleaning and maintenance9
- 21 CFR 211.68Automatic, mechanical, and electronic equipment9
- 21 CFR 211.160General requirements7
Activity by year
2016: 1, 2017: 4, 2018: 5, 2019: 7, 2020: 3, 2022: 1
Where
California 6 · India 4 · Nevada 4 · China 2 · Japan 2 · Arizona 1
Often inspects with
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Inspection history
21 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-11-18 | 483 Eisai Co., Ltd.Nov 18, 2022 · Kamisu-shi, Japan | Kamisu-shi, Japan | 4 | |
| 2020-03-18 | 483 TECHNICHEM CORPMar 18, 2020 · ANAHEIM, California | ANAHEIM, California | 8 | |
| 2020-02-20 | 483 Innovative lntrathecal Solutions, Inc. dbauFeb 20, 2020 · Murrieta, California | Murrieta, California | 10 | |
| 2020-01-10 | 483 NuCare Pharmaceuticals,Inc.Jan 10, 2020 · ORANGE, California | ORANGE, California | 1 | |
| 2019-07-24 | 483 Shandong Luxi Pharmaceutical Co., Ltd.Jul 24, 2019 · Heze, China | Heze, China | 6 | |
| 2019-07-16 | 483 Zhuhai United Laboratories Co., LtdJul 16, 2019 · Zhuhai, China | Zhuhai, China | 8 | |
| 2019-05-24 | 483 Strides Pharma Science LimitedMay 24, 2019 · Bengaluru, India | Bengaluru, India | 4 |
About this profile
What does Rumany C. Penn inspect?
Rumany C. Penn appears on 21 documents on file covering 21 sites, most often in California.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.113 and 21 CFR 211.192.
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 Rumany C. Penn is dated Nov 18, 2022.