Tropical Seas, Inc.
Form 483 issued July 15, 2022 · Holly Hill, Florida
- Inspection
- Jul 11 – Jul 15, 2022
- Investigators
- Jessica M. Simpson· Saundrea A. Munroe
- Observations
- 5
- Pages
- 6
- FEI number
- 1035794
In short: On July 15, 2022, FDA issued a Form 483 with 5 observations to Tropical Seas, Inc. in Holly Hill, Florida (FEI 1035794) after an inspection that ran Jul 11 – Jul 15, 2022. The investigators were Jessica M. Simpson and Saundrea A. Munroe. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 03
The written stability program for drug products does not include reliable…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Jessica M. Simpson
4 documents · 2022–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmTropical Seas, 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tropical Seas, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Tropical Seas, Inc.?
Jessica M. Simpson and Saundrea A. Munroe are named on this Form 483, for the inspection of Jul 11 – Jul 15, 2022. Each investigator has a profile showing what they cite most.
When was Tropical Seas, Inc. inspected by FDA?
The inspection ran Jul 11 – Jul 15, 2022, and the Form 483 is dated July 15, 2022.
How do I get the full Form 483 for Tropical Seas, 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.