Amgen Manufacturing Limited LLC
Form 483 issued August 6, 2018 · Juncos, Puerto Rico
- Inspection
- Jul 23 – Aug 6, 2018
- Investigator
- Vilmary Negron Rodriguez
- Observations
- 2
- Pages
- 3
- FEI number
- 1000110364
In short: On August 6, 2018, FDA issued a Form 483 with 2 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Jul 23 – Aug 6, 2018. The investigator was Vilmary Negron Rodriguez. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Written records of investigations into do not include…
This inspection in context
Vilmary Negron Rodriguez
6 documents · 2015–2018
Cites 211.113 (control of microbiological contamination) 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 211.113(b)
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 and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Amgen Manufacturing Limited LLC?
Vilmary Negron Rodriguez is named on this Form 483, for the inspection of Jul 23 – Aug 6, 2018. Each investigator has a profile showing what they cite most.
When was Amgen Manufacturing Limited LLC inspected by FDA?
The inspection ran Jul 23 – Aug 6, 2018, and the Form 483 is dated August 6, 2018.
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.