Amgen Manufacturing Limited LLC
Form 483 issued January 23, 2015 · Juncos, Puerto Rico
- Inspection
- Jul 28, 2014
- Investigators
- Dennis Cantellops· Jose A. Cruz-Gonzalez
- Observations
- 16
- Pages
- 9
- FEI number
- 1000110364
In short: On January 23, 2015, FDA issued a Form 483 with 16 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Jul 28, 2014. The investigators were Dennis Cantellops and Jose A. Cruz-Gonzalez. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
7 of 10 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The current procedures for the monitoring of the environmental conditions in the drug-product aseptic production areas…
- 02
Operators working in aseptic filling operations do not always document…
- 03
There is no assurance that the media fills performed in the Vial Filling Line in Room…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen Manufacturing Limited LLC?
FDA listed 16 observations on this Form 483, mostly about production and facilities & equipment. 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?
Dennis Cantellops and Jose A. Cruz-Gonzalez are named on this Form 483, for the inspection of Jul 28, 2014. Each investigator has a profile showing what they cite most.
When was Amgen Manufacturing Limited LLC inspected by FDA?
The inspection ran Jul 28, 2014, and the Form 483 is dated January 23, 2015.
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.