Blu Caribe Inc
Form 483 issued March 23, 2016 · Dorado, Puerto Rico
- Inspection
- Feb 29 – Mar 23, 2016
- Investigator
- Jose Velez
- Observations
- 6
- Pages
- 5
- FEI number
- 3008171790
In short: On March 23, 2016, FDA issued a Form 483 with 6 observations to Blu Caribe Inc in Dorado, Puerto Rico (FEI 3008171790) after an inspection that ran Feb 29 – Mar 23, 2016. The investigator was Jose Velez. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBlu Caribe Inc history
All 3 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 Blu Caribe Inc?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Blu Caribe Inc?
Jose Velez is named on this Form 483, for the inspection of Feb 29 – Mar 23, 2016. Each investigator has a profile showing what they cite most.
When was Blu Caribe Inc inspected by FDA?
The inspection ran Feb 29 – Mar 23, 2016, and the Form 483 is dated March 23, 2016.
How do I get the full Form 483 for Blu Caribe Inc?
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.