Tropical Seas, Inc.
Form 483 issued May 30, 2018 · Holly Hill, Florida
- Inspection
- May 21 – May 30, 2018
- Investigator
- Saundrea A. Munroe
- Observations
- 8
- Pages
- 7
- FEI number
- 1035794
In short: On May 30, 2018, FDA issued a Form 483 with 8 observations to Tropical Seas, Inc. in Holly Hill, Florida (FEI 1035794) after an inspection that ran May 21 – May 30, 2018. The investigator was Saundrea A. Munroe. Most observations concern production and quality system.
At a glance
Production and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written record did not include the reason an investigation was found not to be necessary…
- 02
Employees are not given training in the particular operations they perform as part of their function…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) 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 211.198(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tropical Seas, Inc.?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Tropical Seas, Inc.?
Saundrea A. Munroe is named on this Form 483, for the inspection of May 21 – May 30, 2018. Each investigator has a profile showing what they cite most.
When was Tropical Seas, Inc. inspected by FDA?
The inspection ran May 21 – May 30, 2018, and the Form 483 is dated May 30, 2018.
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.