Trone Health Services, Inc.
FDA inspection history in Meridian, Idaho, 2016 to 2017
- 2
- Form 483s
- 1
- Warning letter
- 1
- Response
Every document, by year
- Form 483
- Warning letter
- Response
2016: one 483 response and one Form 483; 2017: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s, one 483 response and one warning letter, at Meridian, Idaho.
- 2016The longest 483 on file: 6 observations over 5 pages at Meridian, Idaho.
Cited most
Across all Trone Health Services observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.42(c)(10)Design and construction features1
The complete Trone Health Services file.
All 4 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
Meridian, Idaho
Two Form 483s, one warning letter and one 483 response · 2016 to 2017 · 7 observations
Latest: Form 483, Dec 8, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-12-08 | 483 Form 483 | Meridian, Idaho | 1 | $99 |
| 2017-03-22 | Warning letter Warning letter | Meridian, Idaho | — | $99 |
| 2016-08-03 | Response 483 response | Meridian, Idaho | — | $199 |
| 2016-07-15 | 483 Form 483 | Meridian, Idaho | 6 | $99 |
Investigators on these documents
FEI number 3012086997 · most recent document Dec 8, 2017
About Trone Health Services, Inc.
How many FDA Form 483s has Trone Health Services, Inc. received?
FDA Intel has 2 Form 483s on file for Trone Health Services, Inc.; the most recent is dated Dec 8, 2017.
When was Trone Health Services, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Trone Health Services, Inc. is a Form 483 dated Dec 8, 2017, for the site in Meridian, Idaho.
What did FDA cite at Trone Health Services, Inc.?
The regulations cited most in the observations on file for Trone Health Services, Inc. are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has Trone Health Services, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Trone Health Services, Inc.; the most recent is dated Mar 22, 2017.