Amgen Manufacturing Limited LLC
FDA inspection history in Juncos, Puerto Rico, 2015 to 2023
- 9
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2018: one Form 483; 2019: three Form 483s; 2020: one Form 483; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–23Nine Form 483s, at Juncos, Puerto Rico.
- 2015The longest 483 on file: 16 observations over 9 pages at Juncos, Puerto Rico.
Cited most
Across all Amgen Manufacturing Limited observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
- 21 CFR 211.188Batch production and control records3
- 21 CFR 211.192Production record review3
The complete Amgen Manufacturing Limited file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Juncos, Puerto Rico
Nine Form 483s · 2015 to 2023 · 43 observations
Latest: Form 483, Jul 5, 2023 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-05 | 483 Form 483 | Juncos, Puerto Rico | 3 | $99 |
| 2021-09-08 | 483 Form 483 | Juncos, Puerto Rico | 4 | $99 |
| 2020-02-27 | 483 Form 483 | Juncos, Puerto Rico | 4 | $99 |
| 2019-09-27 | 483 Form 483 | Juncos, Puerto Rico | 2 | $99 |
| 2019-05-08 | 483 Form 483 | Juncos, Puerto Rico | 4 | $99 |
| 2019-04-11 | 483 Form 483 | Juncos, Puerto Rico | 6 | $99 |
| 2018-08-06 | 483 Form 483 | Juncos, Puerto Rico | 2 | $99 |
| 2017-05-10 | 483 Form 483 | Juncos, Puerto Rico | 2 | $99 |
| 2015-01-23 | 483 Form 483 | Juncos, Puerto Rico | 16 | $99 |
Investigators on these documents
Adaliz Santaliz-Cruz (1)Alan A. Rivera (1)Andrea George (1)Ashley Queen (1)Dennis Cantellops (1)Ivis L. Negron Torres (1)Jennifer Lalama (1)Jose A. Cruz-Gonzalez (1)Jose E. Melendez (1)Maxwell Van Tassell (1)Milva E. Melendez (1)Noreen Muniz (1)
FEI number 1000110364 · most recent document Jul 5, 2023
About Amgen Manufacturing Limited LLC
How many FDA Form 483s has Amgen Manufacturing Limited LLC received?
FDA Intel has 9 Form 483s on file for Amgen Manufacturing Limited LLC; the most recent is dated Jul 5, 2023.
When was Amgen Manufacturing Limited LLC last inspected by FDA?
The most recent FDA inspection document on file for Amgen Manufacturing Limited LLC is a Form 483 dated Jul 5, 2023, for the site in Juncos, Puerto Rico.
What did FDA cite at Amgen Manufacturing Limited LLC?
The regulations cited most in the observations on file for Amgen Manufacturing Limited LLC are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 3 times.