Amgen Manufacturing Limited LLC
Form 483 issued February 27, 2020 · Juncos, Puerto Rico
- Inspection
- Feb 27, 2020
- Investigators
- Wendy G. Tan· Zhong Li
- Observations
- 4
- Pages
- 3
- FEI number
- 1000110364
In short: On February 27, 2020, FDA issued a Form 483 with 4 observations to Amgen Manufacturing Limited LLC in Juncos, Puerto Rico (FEI 1000110364) after an inspection that ran Feb 27, 2020. The investigators were Wendy G. Tan and Zhong Li. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 3 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm has not performed adequate investigations on critical utilities monitoring excursions…
- 02
Your firm lacks adequate assurance that the critical equipment and/or systems, used for the zz process…
- 03
Your firm has not adequately qualified the critical clean utilities used for the 28 manufacturing…
- 04
There is a lack of assurance that your cleaning procedures, used for product-contact process equipment used…
This inspection in context
Wendy G. Tan
11 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Singapore.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen Manufacturing Limited LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Amgen Manufacturing Limited LLC?
Wendy G. Tan and Zhong Li are named on this Form 483, for the inspection of Feb 27, 2020. Each investigator has a profile showing what they cite most.
When was Amgen Manufacturing Limited LLC inspected by FDA?
The inspection ran Feb 27, 2020, and the Form 483 is dated February 27, 2020.
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.