Emergent Manufacturing Operations Baltimore, LLC

Form 483 issued April 20, 2020 · Baltimore, Maryland

Inspection: Apr 9 – Apr 20, 2020
Investigator: Marcellinus D. Dordunoo
Observations: 5
Pages: 6
FEI number: 3015448605

In short: On April 20, 2020, FDA issued a Form 483 with 5 observations to Emergent Manufacturing Operations Baltimore, LLC in Baltimore, Maryland (FEI 3015448605) after an inspection that ran Apr 9 – Apr 20, 2020. The investigator was Marcellinus D. Dordunoo. Most observations concern quality system and facilities & equipment.

At a glance

Quality system and facilities & equipment account for 3 of 5 observations.

Quality system2

Facilities & equipment1

Laboratory controls1

Materials1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.68 21 CFR 211.194
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
02
21 CFR 211.160
Established specifications, test procedures and laboratory control mechanisms are not followed and documented at…
03
21 CFR 211.22
The responsibilities and procedures applicable to the quality control unit are not in…
04
21 CFR 211.25
Employees are not given training in the particular operations they perform as part of their function…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Marcellinus D. Dordunoo

21 documents · 2017–2026

Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.

The firm

Emergent Manufacturing Operations Baltimore, LLC history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.68

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483May 8, 2020$199

Emergent Manufacturing Operations Baltimore, LLC site file

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Questions about this 483

What did FDA find at Emergent Manufacturing Operations Baltimore, LLC?

FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.

Who inspected Emergent Manufacturing Operations Baltimore, LLC?

Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Apr 9 – Apr 20, 2020. Each investigator has a profile showing what they cite most.

When was Emergent Manufacturing Operations Baltimore, LLC inspected by FDA?

The inspection ran Apr 9 – Apr 20, 2020, and the Form 483 is dated April 20, 2020.

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.