Blu Caribe Inc
Form 483 issued July 2, 2021 · Dorado, Puerto Rico
- Inspection
- Jun 15 – Jul 2, 2021
- Investigators
- Ivis L. Negron Torres· Marian E. Ramirez
- Observations
- 9
- Pages
- 11
- FEI number
- 3008171790
In short: On July 2, 2021, FDA issued a Form 483 with 9 observations to Blu Caribe Inc in Dorado, Puerto Rico (FEI 3008171790) after an inspection that ran Jun 15 – Jul 2, 2021. The investigators were Ivis L. Negron Torres and Marian E. Ramirez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 8 of 9 observations.
Most cited: 21 CFR 211.160(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The written stability program does not assure testing of the drug product in the same container-closure…
- 02
The written stability testing…
- 03
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do…
- 04
EUPLOYEE(S) SIGNATURE Established laboratory control…
This inspection in context
Ivis L. Negron Torres
6 documents · 2017–2026
Cites 211.160 (general requirements) 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 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blu Caribe Inc?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Blu Caribe Inc?
Ivis L. Negron Torres and Marian E. Ramirez are named on this Form 483, for the inspection of Jun 15 – Jul 2, 2021. Each investigator has a profile showing what they cite most.
When was Blu Caribe Inc inspected by FDA?
The inspection ran Jun 15 – Jul 2, 2021, and the Form 483 is dated July 2, 2021.
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.