Nancy M. Espinal
FDA investigator
Appears on 16 documents from 2016 to 2022, mostly at sites in New Jersey. Most often cites production record review (21 CFR 211.192).
- 16
- Documents on file
- 6.8
- Observations per 483
- 2016
- First seen
- 2022
- Most recent
What they cite most
From 109 observations- 21 CFR 211.192Production record review12
- 21 CFR 211.160General requirements10
- 21 CFR 211.194Laboratory records9
- 21 CFR 211.67Equipment cleaning and maintenance9
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.165Testing and release for distribution7
Activity by year
2016: 2, 2017: 2, 2018: 1, 2019: 5, 2020: 2, 2021: 3, 2022: 1
Where
New Jersey 11 · India 2 · France 1 · Massachusetts 1 · Pennsylvania 1
Often inspects with
Rita K. Kabaso· Barbara J. Wilimczyk-Macri· Kristina L. Conroy
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Inspection history
16 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-12-16 | 483 CIS Bio InternationalDec 16, 2022 · Gif sur Yvette, France | Gif sur Yvette, France | 8 | |
| 2021-10-29 | 483 Dr. Reddy's Laboratories Ltd.Oct 29, 2021 · Duvvada, India | Duvvada, India | 8 | |
| 2021-10-16 | 483 Symed Labs LimitedOct 16, 2021 · Yadadri Bhuvangiri, India | Yadadri Bhuvangiri, India | 3 | |
| 2021-08-31 | 483 Teligent, Inc.Aug 31, 2021 · Buena, New Jersey | Buena, New Jersey | 15 | |
| 2020-10-09 | 483 EHT Pharmacy LLC dba CurexaOct 9, 2020 · Egg Harbor Township, New Jersey | Egg Harbor Township, New Jersey | 3 | |
| 2020-03-13 | 483 KVK-TECH, INC.Mar 13, 2020 · Newtown, Pennsylvania | Newtown, Pennsylvania | 11 | |
| 2019-09-25 | 483 AptaPharma Inc.Sep 25, 2019 · Pennsauken, New Jersey | Pennsauken, New Jersey | 2 |
About this profile
What does Nancy M. Espinal inspect?
Nancy M. Espinal appears on 16 documents on file covering 14 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.160 and 21 CFR 211.194.
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 Nancy M. Espinal is dated Dec 16, 2022.