SCS Direct Inc
FDA inspection history in Trumbull, Connecticut, 2016 to 2023
- 2
- Warning letters
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Warning letter
- Close-out
- Form 483
2016: one warning letter and one Form 483; 2017: one close-out letter; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One warning letter, one Form 483 and one close-out letter, at Trumbull, Connecticut.
- 2023One warning letter, at Trumbull, Connecticut.
Cited most
Across all SCS Direct observations on file
- 21 CFR 211.150(b)Distribution procedures1
- 21 CFR 211.196Distribution records1
- 21 CFR 211.198(a)Complaint files1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
The complete SCS Direct 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
Trumbull, Connecticut
Two warning letters, one close-out letter and one Form 483 · 2016 to 2023 · 5 observations
Latest: Warning letter, Apr 6, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-06 | Warning letter Warning letter | Trumbull, Connecticut | — | $99 |
| 2017-09-11 | Close-out Close-out letter | Trumbull, Connecticut | — | $99 |
| 2016-10-18 | Warning letter Warning letter | Trumbull, Connecticut | — | $99 |
| 2016-08-23 | 483 Form 483 | Trumbull, Connecticut | 5 | $99 |
Investigators on these documents
FEI number 3012113857 · most recent document Apr 6, 2023
About SCS Direct Inc
How many FDA Form 483s has SCS Direct Inc received?
FDA Intel has 1 Form 483 on file for SCS Direct Inc; the most recent is dated Aug 23, 2016.
When was SCS Direct Inc last inspected by FDA?
The most recent FDA inspection document on file for SCS Direct Inc is a Form 483 dated Aug 23, 2016, for the site in Trumbull, Connecticut.
What did FDA cite at SCS Direct Inc?
The regulations cited most in the observations on file for SCS Direct Inc are 21 CFR 211.150(b) (Distribution procedures), 1 time; 21 CFR 211.196 (Distribution records), 1 time; 21 CFR 211.198(a) (Complaint files), 1 time.
Has SCS Direct Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for SCS Direct Inc; the most recent is dated Apr 6, 2023.