Noreen Muniz
FDA investigator · also recorded as Of Thes Noreen Muniz, Us Noreen Muniz
Appears on 24 documents from 2008 to 2022, mostly at sites in Puerto Rico. Most often cites general requirements (21 CFR 211.160).
- 24
- Documents on file
- 5.7
- Observations per 483
- 2008
- First seen
- 2022
- Most recent
What they cite most
From 130 observations- 21 CFR 211.160General requirements15
- 21 CFR 211.67Equipment cleaning and maintenance14
- 21 CFR 211.192Production record review11
- 21 CFR 211.42Design and construction features10
- 21 CFR 211.22Responsibilities of quality control unit9
- 21 CFR 211.113Control of microbiological contamination7
Activity by year
2008: 1, 2012: 2, 2013: 2, 2014: 1, 2015: 2, 2016: 6, 2017: 2, 2018: 1, 2019: 4, 2020: 1, 2022: 2
Where
Puerto Rico 12 · Florida 3 · Maryland 3 · Japan 2 · China 1 · Georgia 1
Often inspects with
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Inspection history
24 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-12-09 | 483 Kyowa Pharma Chemical Co., Ltd.Dec 9, 2022 · Takaoka, Japan | Takaoka, Japan | 8 | |
| 2022-12-02 | 483 Bushu Pharmaceuticals Ltd.Dec 2, 2022 · Kawagoe, Japan | Kawagoe, Japan | 3 | |
| 2020-02-20 | 483 Knoll LLCFeb 20, 2020 · Jayuya, Puerto Rico | Jayuya, Puerto Rico | 4 | |
| 2019-12-20 | 483 Viatris Pharmaceuticals LLCDec 20, 2019 · Barceloneta, Puerto Rico | Barceloneta, Puerto Rico | 3 | |
| 2019-11-04 | 483 Form 483 · FEI 3013133723Nov 4, 2019 · Sarasota, Florida | Sarasota, Florida | 8 | |
| 2019-09-27 | 483 Amgen Manufacturing Limited LLCSep 27, 2019 · Juncos, Puerto Rico | Juncos, Puerto Rico | 2 | |
| 2019-03-22 | 483 Bayer AGMar 22, 2019 · Leverkusen, Germany | Leverkusen, Germany | 6 |
About this profile
What does Noreen Muniz inspect?
Noreen Muniz appears on 24 documents on file covering 20 sites, mostly in Puerto Rico.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.67 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 Noreen Muniz is dated Dec 9, 2022.