Tropical Seas, Inc.
FDA inspection history in Holly Hill, Florida, 2018 to 2022
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2018: one Form 483; 2019: one close-out letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19One Form 483 and one close-out letter, at Holly Hill, Florida.
- 2018The longest 483 on file: 8 observations over 7 pages at Holly Hill, Florida.
- 2022One Form 483, at Holly Hill, Florida.
Cited most
Across all Tropical Seas observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.101(d)Charge-in of components1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete Tropical Seas file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Holly Hill, Florida
Two Form 483s and one close-out letter · 2018 to 2022 · 13 observations
Latest: Form 483, Jul 15, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-15 | 483 Form 483 | Holly Hill, Florida | 5 | $99 |
| 2019-05-15 | Close-out Close-out letter | Holly Hill, Florida | — | $99 |
| 2018-05-30 | 483 Form 483 | Holly Hill, Florida | 8 | $99 |
Investigators on these documents
FEI number 1035794 · most recent document Jul 15, 2022
About Tropical Seas, Inc.
How many FDA Form 483s has Tropical Seas, Inc. received?
FDA Intel has 2 Form 483s on file for Tropical Seas, Inc.; the most recent is dated Jul 15, 2022.
When was Tropical Seas, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Tropical Seas, Inc. is a Form 483 dated Jul 15, 2022, for the site in Holly Hill, Florida.
What did FDA cite at Tropical Seas, Inc.?
The regulations cited most in the observations on file for Tropical Seas, Inc. are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.