Tri-Coast Pharmacy, Inc.
FDA inspection history in Juno Beach, Florida, 2016 to 2018
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2018: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18One Form 483 and one warning letter, at Juno Beach, Florida.
Cited most
Across all Tri-Coast Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling1
The complete Tri-Coast Pharmacy file.
All 2 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
Juno Beach, Florida
One warning letter and one Form 483 · 2016 to 2018 · 9 observations
Latest: Warning letter, Aug 20, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-20 | Warning letter Warning letter | Juno Beach, Florida | — | $99 |
| 2016-10-14 | 483 Form 483 | Juno Beach, Florida | 9 | $99 |
Investigators on these documents
FEI number 3011827553 · most recent document Aug 20, 2018
About Tri-Coast Pharmacy, Inc.
How many FDA Form 483s has Tri-Coast Pharmacy, Inc. received?
FDA Intel has 1 Form 483 on file for Tri-Coast Pharmacy, Inc.; the most recent is dated Oct 14, 2016.
When was Tri-Coast Pharmacy, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Tri-Coast Pharmacy, Inc. is a Form 483 dated Oct 14, 2016, for the site in Juno Beach, Florida.
What did FDA cite at Tri-Coast Pharmacy, Inc.?
The regulations cited most in the observations on file for Tri-Coast Pharmacy, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.28 (Personnel responsibilities), 1 time.
Has Tri-Coast Pharmacy, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Tri-Coast Pharmacy, Inc.; the most recent is dated Aug 20, 2018.