Blu Caribe Inc
Form 483 issued August 14, 2015 · I Dorado, Puerto Rico
- Inspection
- Aug 4 – Aug 14, 2015
- Investigators
- Dewayne Whitlock· Jose Velez· Zhongren Wu
- Observations
- 2
- Pages
- 3
- FEI number
- 3008171790
In short: On August 14, 2015, FDA issued a Form 483 with 2 observations to Blu Caribe Inc in I Dorado, Puerto Rico (FEI 3008171790) after an inspection that ran Aug 4 – Aug 14, 2015. The investigators were Dewayne Whitlock, Jose Velez and Zhongren Wu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.56 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent that would alter…
This inspection in context
Dewayne Whitlock
1 document · 2015
Cites 211.56 (sanitation) 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 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blu Caribe Inc?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Blu Caribe Inc?
Dewayne Whitlock, Jose Velez and Zhongren Wu are named on this Form 483, for the inspection of Aug 4 – Aug 14, 2015. Each investigator has a profile showing what they cite most.
When was Blu Caribe Inc inspected by FDA?
The inspection ran Aug 4 – Aug 14, 2015, and the Form 483 is dated August 14, 2015.
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.