Amgen Manufacturing Limited LLC
Form 483 issued July 5, 2023 · Juncos, Puerto Rico
- Inspection
- Jun 20 – Jul 5, 2023
- Investigators
- Alan A. Rivera· Ivis L. Negron Torres
- Observations
- 3
- Pages
- 10
- FEI number
- 1000110364
In short: On July 5, 2023, FDA issued a Form 483 with 3 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Jun 20 – Jul 5, 2023. The investigators were Alan A. Rivera and Ivis L. Negron Torres. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 02
The written stability program for drug products does not include test intervals based on statistical criteria…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) 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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen Manufacturing Limited LLC?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Amgen Manufacturing Limited LLC?
Alan A. Rivera and Ivis L. Negron Torres are named on this Form 483, for the inspection of Jun 20 – Jul 5, 2023. Each investigator has a profile showing what they cite most.
When was Amgen Manufacturing Limited LLC inspected by FDA?
The inspection ran Jun 20 – Jul 5, 2023, and the Form 483 is dated July 5, 2023.
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.