Sentara Enterprises
FDA inspection history in Chesapeake, Virginia, 2015 to 2022
- 3
- Form 483s
- 1
- Warning letter
- 1
- Response
Every document, by year
- Form 483
- Warning letter
- Response
2015: one 483 response and one Form 483; 2016: one warning letter; 2018: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s, one 483 response and one warning letter, at Chesapeake, Virginia.
- 2015The longest 483 on file: 11 observations over 6 pages at Chesapeake, Virginia.
- 2022One Form 483, at Chesapeake, Virginia.
Cited most
Across all Sentara Enterprises observations on file
- 21 CFR 211.113Control of microbiological contamination8
- FDCA 501(a)(2)(A)Insanitary conditions8
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.137Expiration dating1
The complete Sentara Enterprises file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Chesapeake, Virginia
Three Form 483s, one warning letter and one 483 response · 2015 to 2022 · 29 observations
Latest: Form 483, Dec 16, 2022 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-16 | 483 Form 483 | Chesapeake, Virginia | 10 | $99 |
| 2018-08-06 | 483 Form 483 | Chesapeake, Virginia | 8 | $99 |
| 2016-08-08 | Warning letter Warning letter | Chesapeake, Virginia | — | $99 |
| 2015-08-12 | Response 483 response | Chesapeake, Virginia | — | $199 |
| 2015-07-23 | 483 Form 483 | Chesapeake, Virginia | 11 | $99 |
Investigators on these documents
Wilfred A. Darang (2)Brandy N. Lepage (1)Karen A. Briggs (1)Mindy M. Chou (1)Nebil A. Oumer (1)Sena G. Dissmeyer (1)
FEI number 3011627411 · most recent document Dec 16, 2022
About Sentara Enterprises
How many FDA Form 483s has Sentara Enterprises received?
FDA Intel has 3 Form 483s on file for Sentara Enterprises; the most recent is dated Dec 16, 2022.
When was Sentara Enterprises last inspected by FDA?
The most recent FDA inspection document on file for Sentara Enterprises is a Form 483 dated Dec 16, 2022, for the site in Chesapeake, Virginia.
What did FDA cite at Sentara Enterprises?
The regulations cited most in the observations on file for Sentara Enterprises are 21 CFR 211.113 (Control of microbiological contamination), 8 times; FDCA 501(a)(2)(A) (Insanitary conditions), 8 times; 21 CFR 211.42 (Design and construction features), 5 times.
Has Sentara Enterprises received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sentara Enterprises; the most recent is dated Aug 8, 2016.