Emergen
Form 483 issued April 20, 2021 · Baltimore, Maryland
- Inspection
- Apr 12 – Apr 20, 2021
- Investigators
- Cody D. Rickman· Ly D. Rickman
- Observations
- 9
- Pages
- 13
- FEI number
- 5448605
In short: On April 20, 2021, FDA issued a Form 483 with 9 observations to Emergen in Baltimore, Maryland (FEI 5448605) after an inspection that ran Apr 12 – Apr 20, 2021. The investigators were Cody D. Rickman and Ly D. Rickman.
What FDA observed
Preview: the opening words of each observation- 01
Failure to conduct thorough…
- 02
The building used for the manufacture of the client®Y@ viral vaccine drug substance and client viral…
- 03
The building used for the manufacture of the client viral vaccine drug substance and client viral…
- 04
Written production and process control procedures to prevent cross-contamination are not followed in the execution of…
This inspection in context
Cody D. Rickman
8 documents · 2011–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Maryland.
The firmEmergen history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Emergen?
FDA listed 9 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Emergen?
Cody D. Rickman and Ly D. Rickman are named on this Form 483, for the inspection of Apr 12 – Apr 20, 2021. Each investigator has a profile showing what they cite most.
When was Emergen inspected by FDA?
The inspection ran Apr 12 – Apr 20, 2021, and the Form 483 is dated April 20, 2021.
How do I get the full Form 483 for Emergen?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.