Amgen Manufacturing Limited LLC
Form 483 issued September 27, 2019 · Juncos, Puerto Rico
- Inspection
- Sep 23 – Sep 27, 2019
- Investigator
- Noreen Muniz
- Observations
- 2
- Pages
- 3
- FEI number
- 1000110364
In short: On September 27, 2019, FDA issued a Form 483 with 2 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Sep 23 – Sep 27, 2019. The investigator was Noreen Muniz. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (1×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include complete information relating to the production and…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) 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 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen Manufacturing Limited LLC?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Amgen Manufacturing Limited LLC?
Noreen Muniz is named on this Form 483, for the inspection of Sep 23 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was Amgen Manufacturing Limited LLC inspected by FDA?
The inspection ran Sep 23 – Sep 27, 2019, and the Form 483 is dated September 27, 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.