Trimed Inc
FDA inspection history in Santa Clarita, California, 2016 to 2019
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2016: one warning letter and one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter and one Form 483, at Santa Clarita, California.
- 2019One close-out letter, at Santa Clarita, California.
Cited most
Across all Trimed observations on file
- 21 CFR 820.30(a)Design controls2
- 21 CFR 803.12(a)How do I submit initial and supplemental or followup reports?1
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.19Are there exemptions, variances, or alternative forms of adverse event reporting requirements?1
- 21 CFR 803.20How do I complete and submit an individual adverse event report?1
The complete Trimed 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
Santa Clarita, California
One close-out letter, one warning letter and one Form 483 · 2016 to 2019 · 1 observation
Latest: Close-out, Oct 11, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-10-11 | Close-out Close-out letter | Santa Clarita, California | — | $99 |
| 2016-06-30 | Warning letter Warning letter | Santa Clarita, California | — | $99 |
| 2016-03-18 | 483 Form 483 | Santa Clarita, California | 1 | $99 |
Investigators on these documents
FEI number 3001236812 · most recent document Oct 11, 2019
About Trimed Inc
How many FDA Form 483s has Trimed Inc received?
FDA Intel has 1 Form 483 on file for Trimed Inc; the most recent is dated Mar 18, 2016.
When was Trimed Inc last inspected by FDA?
The most recent FDA inspection document on file for Trimed Inc is a Form 483 dated Mar 18, 2016, for the site in Santa Clarita, California.
What did FDA cite at Trimed Inc?
The regulations cited most in the observations on file for Trimed Inc are 21 CFR 820.30(a) (Design controls), 2 times; 21 CFR 803.12(a) (How do I submit initial and supplemental or followup reports?), 1 time; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time.
Has Trimed Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Trimed Inc; the most recent is dated Jun 30, 2016.