Melissa T. Roy
FDA investigator
Appears on 6 documents from 2016 to 2018, mostly at sites in New Jersey. Most often cites written procedures; deviations (21 CFR 211.100).
- 6
- Documents on file
- 6.2
- Observations per 483
- 2016
- First seen
- 2018
- Most recent
What they cite most
From 37 observations- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.165Testing and release for distribution4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 314.80Postmarketing reporting of adverse drug experiences4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements3
Activity by year
2016: 3, 2017: 1, 2018: 2
Where
New Jersey 4 · West Virginia 2
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-09-25 | 483 Loop Plaza Pharmacy Company DBA Loop Compounding PharamacySep 25, 2018 · Saint Albans, West Virginia | Saint Albans, West Virginia | 4 | |
| 2018-04-12 | 483 Mylan Pharmaceuticals Inc.Apr 12, 2018 · Morgantown, West Virginia | Morgantown, West Virginia | 13 | |
| 2017-01-25 | 483 CELGENE CORPORATIONJan 25, 2017 · SUMMIT, New Jersey | SUMMIT, New Jersey | 1 | |
| 2016-07-19 | 483 Sewaren Innovative Pharmaceutical Packaging dba SIPPJul 19, 2016 · Avenel, New Jersey | Avenel, New Jersey | 3 | |
| 2016-03-18 | 483 Us,Organic Group CorpMar 18, 2016 · Passaic, New Jersey | Passaic, New Jersey | 7 | |
| 2016-02-02 | 483 Elite Laboratories IncFeb 2, 2016 · Northvale, New Jersey | Northvale, New Jersey | 9 |
About this profile
What does Melissa T. Roy inspect?
Melissa T. Roy appears on 6 documents on file covering 6 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.165 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 Melissa T. Roy is dated Sep 25, 2018.