Vilmary Negron Rodriguez
FDA investigator
Appears on 6 documents from 2015 to 2018, mostly at sites in Puerto Rico. Most often cites control of microbiological contamination (21 CFR 211.113).
- 6
- Documents on file
- 3.7
- Observations per 483
- 2015
- First seen
- 2018
- Most recent
What they cite most
From 22 observations- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review3
- 21 CFR 211.42(c)(10)Design and construction features3
- 21 CFR 211.160(b)(1)General requirements2
- 21 CFR 211.67(b)Equipment cleaning and maintenance2
- 21 CFR 211.110(a)(5)Sampling and testing of in-process materials and drug products1
Activity by year
2015: 3, 2016: 1, 2018: 2
Where
Puerto Rico 3 · Arizona 1 · India 1 · Texas 1
Often inspects with
Ariel Cruz Figueroa· Binh T. Nguyen· Dennis Cantellops Paite
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-12-14 | 483 Intas Pharmaceuticals LimitedDec 14, 2018 · Ahmedabad, India | Ahmedabad, India | 1 | |
| 2018-08-06 | 483 Amgen Manufacturing LimitedAug 6, 2018 · Juncos, Puerto Rico | Juncos, Puerto Rico | 2 | |
| 2016-06-21 | 483 Patheon Puerto Rico, IncJun 21, 2016 · Manati, Puerto Rico | Manati, Puerto Rico | 1 | |
| 2015-12-11 | 483 NATIONAL VITAMIN COMPANYDec 11, 2015 · Casa Grande, Arizona | Casa Grande, Arizona | 5 | |
| 2015-08-05 | 483 American Specialty PharmacyAug 5, 2015 · Dallas, Texas | Dallas, Texas | 10 | |
| 2015-05-29 | 483 Janssen Ortho LLCMay 29, 2015 · Gurabo, Puerto Rico | Gurabo, Puerto Rico | 3 |
About this profile
What does Vilmary Negron Rodriguez inspect?
Vilmary Negron Rodriguez appears on 6 documents on file covering 6 sites, mostly in Puerto Rico.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.42(c)(10).
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 Vilmary Negron Rodriguez is dated Dec 14, 2018.