Amgen Manufacturing Limited LLC

Form 483 issued May 8, 2019 · Juncos, Puerto Rico

Inspection: Apr 30 – May 8, 2019
Investigators: Andrea George· Ashley Queen· Maxwell Van Tassell
Observations: 4
Pages: 3
FEI number: 1000110364

In short: On May 8, 2019, FDA issued a Form 483 with 4 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Apr 30 – May 8, 2019. The investigators were Andrea George, Ashley Queen, Maxwell Van Tassell and Riley Myers. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

Production and facilities & equipment account for 3 of 4 observations.

Production2

Facilities & equipment1

Biologics CGMP1

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 211.113
Controls in place to prevent contamination of the Enbrel (etanercept) drug substance…
02
21 CFR 211.100
Performance qualification activities for the Enbrel drug substance manufacturing process at…
03
21 CFR 211.67
Corrective and preventive actions are not adequate to address potential leaks in process transfer lines. For…
04
21 CFR 601.12
The Enbrel drug substance manufacturing process is not in conformance with the…

The full 483

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This inspection in context

The investigator

Andrea George

2 documents · 2019–2022

Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.

The firm

Amgen Manufacturing Limited LLC history

All 9 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at Amgen Manufacturing Limited LLC?

FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and biologics CGMP. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

Who inspected Amgen Manufacturing Limited LLC?

Andrea George, Ashley Queen, Maxwell Van Tassell and Riley Myers are named on this Form 483, for the inspection of Apr 30 – May 8, 2019. Each investigator has a profile showing what they cite most.

When was Amgen Manufacturing Limited LLC inspected by FDA?

The inspection ran Apr 30 – May 8, 2019, and the Form 483 is dated May 8, 2019.

How do I get the full Form 483 for Amgen Manufacturing Limited 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.