Blu Caribe Inc
FDA inspection history across 2 sites, 2015 to 2021
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16Two Form 483s, at I Dorado, Puerto Rico and Dorado, Puerto Rico.
- 2021One Form 483, at Dorado, Puerto Rico.
- 2021The longest 483 on file: 9 observations over 11 pages at Dorado, Puerto Rico.
Cited most
Across all Blu Caribe observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.166Stability testing3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.137Expiration dating1
- 21 CFR 211.165Testing and release for distribution1
The complete Blu Caribe file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Dorado, Puerto Rico
Two Form 483s · 2016 to 2021 · 15 observations
Latest: Form 483, Jul 2, 2021 →I Dorado, Puerto Rico
One Form 483 · 2015 · 2 observations
Latest: Form 483, Aug 14, 2015 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-07-02 | 483 Form 483 | Dorado, Puerto Rico | 9 | $99 |
| 2016-03-23 | 483 Form 483 | Dorado, Puerto Rico | 6 | $99 |
| 2015-08-14 | 483 Form 483 | I Dorado, Puerto Rico | 2 | $99 |
Investigators on these documents
Jose Velez (2)Dewayne Whitlock (1)Ivis L. Negron Torres (1)Marian E. Ramirez (1)Zhongren Wu (1)
FEI number 3008171790 · most recent document Jul 2, 2021
About Blu Caribe Inc
How many FDA Form 483s has Blu Caribe Inc received?
FDA Intel has 3 Form 483s on file for Blu Caribe Inc; the most recent is dated Jul 2, 2021.
When was Blu Caribe Inc last inspected by FDA?
The most recent FDA inspection document on file for Blu Caribe Inc is a Form 483 dated Jul 2, 2021, for the site in Dorado, Puerto Rico.
What did FDA cite at Blu Caribe Inc?
The regulations cited most in the observations on file for Blu Caribe Inc are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.166 (Stability testing), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times.