Amgen Manufacturing Limited LLC
Form 483 issued September 8, 2021 · Juncos, Puerto Rico
- Inspection
- Aug 30 – Sep 8, 2021
- Investigator
- Milva E. Melendez
- Observations
- 4
- Pages
- 3
- FEI number
- 1000110364
In short: On September 8, 2021, FDA issued a Form 483 with 4 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Aug 30 – Sep 8, 2021. The investigator was Milva E. Melendez. Most observations concern materials and production.
At a glance
Materials and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of components from unqualified suppliers are not tested for conformity with all appropriate written…
- 02
Not all production events and process control actions are documented at the time, 2 they…
- 03
Failure to thoroughly investigate unexpected results…
- 04
Inventory records of cach component do not include accurate information to allow rapid determination of status…
This inspection in context
Milva E. Melendez
1 document · 2021
Cites 211.184 (component, drug product container, closure, and labeling records) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAmgen Manufacturing Limited LLC history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen Manufacturing Limited LLC?
FDA listed 4 observations on this Form 483, mostly about materials, production and quality system. The opening words of each observation are shown on this page.
Who inspected Amgen Manufacturing Limited LLC?
Milva E. Melendez is named on this Form 483, for the inspection of Aug 30 – Sep 8, 2021. Each investigator has a profile showing what they cite most.
When was Amgen Manufacturing Limited LLC inspected by FDA?
The inspection ran Aug 30 – Sep 8, 2021, and the Form 483 is dated September 8, 2021.
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.