FDA Intel

Amgen Manufacturing Limited LLC

Form 483 issued April 11, 2019 · Juncos, Puerto Rico

Inspection
Apr 1 – Apr 11, 2019
Investigators
Adaliz Santaliz-Cruz· Jennifer Lalama· Jose E. Melendez
Observations
6
Pages
10
FEI number
1000110364

In short: On April 11, 2019, FDA issued a Form 483 with 6 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Apr 1 – Apr 11, 2019. The investigators were Adaliz Santaliz-Cruz, Jennifer Lalama and Jose E. Melendez. Most observations concern quality system and biologics CGMP.

At a glance

Observations span 4 systems, led by quality system.

Quality system2
Biologics CGMP1
Design controls1
CAPA1
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit are not fully followed. The list…

  2. 02
    21 CFR 211.198(a)

    EMPLOVEE(S) SONATURE Complaint procedures are deficient in that they do not include provisions that allow for…

  3. 03
    21 CFR 606.17121 CFR 820

    Failure to submit a biological product deviation report within 45 days from the date you acquired…

  4. 04
    21 CFR 820.30(f)

    Design verification does not confirm that design output…

2 more observations

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

Get the full 483

This inspection in context

The investigator

Adaliz Santaliz-Cruz

6 documents · 2012–2022

Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.

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 211.22(d)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Amgen Manufacturing Limited LLC?

FDA listed 6 observations on this Form 483, mostly about quality system, biologics CGMP and design controls. The opening words of each observation are shown on this page.

Who inspected Amgen Manufacturing Limited LLC?

Adaliz Santaliz-Cruz, Jennifer Lalama and Jose E. Melendez are named on this Form 483, for the inspection of Apr 1 – Apr 11, 2019. Each investigator has a profile showing what they cite most.

When was Amgen Manufacturing Limited LLC inspected by FDA?

The inspection ran Apr 1 – Apr 11, 2019, and the Form 483 is dated April 11, 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.

$99Get it free