Sentara Enterprises
Form 483 issued December 16, 2022 · Chesapeake, Virginia
- Inspection
- Dec 5 – Dec 16, 2022
- Investigators
- Brandy N. Lepage· Karen A. Briggs· Sena G. Dissmeyer
- Observations
- 10
- Pages
- 10
- FEI number
- 3011627411
In short: On December 16, 2022, FDA issued a Form 483 with 10 observations to Sentara Enterprises in Chesapeake, Virginia (FEI 3011627411) after an inspection that ran Dec 5 – Dec 16, 2022. The investigators were Brandy N. Lepage, Karen A. Briggs and Sena G. Dissmeyer. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: FDCA 501(a)(2)(A) (8×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 02FDCA 501(a)(2)(A)
EMPI.OYEE(S) SIGNATURE -« You did not make adequate product evaluation and take remedial action where actionable…
- 03FDCA 501(a)(2)(A)
You produced beta-lactam diugs without providing adequate cleaning of work surfaces…
- 04FDCA 501(a)(2)(A)
Personnel engaged in aseptic processing were observed with exposed…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmSentara Enterprises history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sentara Enterprises?
FDA listed 10 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sentara Enterprises?
Brandy N. Lepage, Karen A. Briggs and Sena G. Dissmeyer are named on this Form 483, for the inspection of Dec 5 – Dec 16, 2022. Each investigator has a profile showing what they cite most.
When was Sentara Enterprises inspected by FDA?
The inspection ran Dec 5 – Dec 16, 2022, and the Form 483 is dated December 16, 2022.
How do I get the full Form 483 for Sentara Enterprises?
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