Emergent Manufacturing Operations Baltimore, LLC
Form 483 issued April 20, 2021 · Baltimore, Maryland
- Inspection
- Apr 12 – Apr 20, 2021
- Investigators
- Cody D. Rickman· Debra M. Emerson
- Observations
- 9
- Pages
- 14
- FEI number
- 3015448605
In short: On April 20, 2021, FDA issued a Form 483 with 9 observations to Emergent Manufacturing Operations Baltimore, LLC in Baltimore, Maryland (FEI 3015448605) after an inspection that ran Apr 12 – Apr 20, 2021. The investigators were Cody D. Rickman and Debra M. Emerson. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to conduct thorough…
- 02
The bui lding used for the manufacture of the client{b) (4 ) viral vaccine drug substance…
- 03
The building used for the manufacture of the client (b)(4) viral vaccine drug substance and client…
- 04
Written production and process control procedures to prevent cross-contamination arc 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 firmEmergent Manufacturing Operations Baltimore, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Emergent Manufacturing Operations Baltimore, LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Emergent Manufacturing Operations Baltimore, LLC?
Cody D. Rickman and Debra M. Emerson 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 Emergent Manufacturing Operations Baltimore, LLC 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 Emergent Manufacturing Operations Baltimore, LLC?
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.