Pharmacaribe, LLC
Form 483 issued August 20, 2025 · Punta Gorda, Florida
- Inspection
- Aug 18 – Aug 20, 2025
- Investigator
- Gisselle I. Sensebe
- Observations
- 6
- Pages
- 5
- FEI number
- 3006500694
In short: On August 20, 2025, FDA issued a Form 483 with 6 observations to Pharmacaribe, LLC in Punta Gorda, Florida (FEI 3006500694) after an inspection that ran Aug 18 – Aug 20, 2025. The investigator was Gisselle I. Sensebe. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Management controls and capa account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of labeling to meet any of its specifications were not evaluated…
- 0221 CFR 820.20(b)21 CFR 820
The organizational structure has not been adequately established and maintained to ensure that devices are produced…
- 03
Quality audits have not…
- 04
Corrective and preventive action activities and/or results have…
This inspection in context
Gisselle I. Sensebe
3 documents · 2022–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmPharmacaribe, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmacaribe, LLC?
FDA listed 6 observations on this Form 483, mostly about management controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Pharmacaribe, LLC?
Gisselle I. Sensebe is named on this Form 483, for the inspection of Aug 18 – Aug 20, 2025. Each investigator has a profile showing what they cite most.
When was Pharmacaribe, LLC inspected by FDA?
The inspection ran Aug 18 – Aug 20, 2025, and the Form 483 is dated August 20, 2025.
How do I get the full Form 483 for Pharmacaribe, LLC?
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.