Amgen Manufacturing Limited LLC
Form 483 issued May 10, 2017 · Juncos, Puerto Rico
- Inspection
- Apr 26 – May 10, 2017
- Observations
- 2
- Pages
- 4
- FEI number
- 1000110364
In short: On May 10, 2017, FDA issued a Form 483 with 2 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Apr 26 – May 10, 2017. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(a) (1×) · 211.180(e)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures describing the handling of complaints do not include provisions for a determination as to…
- 02
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
This inspection in context
Questions about this 483
What did FDA find at Amgen Manufacturing Limited LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
When was Amgen Manufacturing Limited LLC inspected by FDA?
The inspection ran Apr 26 – May 10, 2017, and the Form 483 is dated May 10, 2017.
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.