Coupler Enterprises
FDA inspection history across 2 sites, 2020 to 2023
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2020: one close-out letter and one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One close-out letter and one warning letter, at Warrington, Pennsylvania.
- 2023One Form 483, at Horsham, Pennsylvania.
Cited most
Across all Coupler Enterprises observations on file
- 21 CFR 211.122(g)(3)Materials examination and usage criteria1
- 21 CFR 211.130(e)Packaging and labeling operations1
- 21 CFR 211.170(b)Reserve samples1
- 21 CFR 211.186(b)(7)Master production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Coupler Enterprises 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
Warrington, Pennsylvania
One close-out letter and one warning letter · 2020
Latest: Close-out, Sep 15, 2020 →Horsham, Pennsylvania
One Form 483 · 2023 · 6 observations
Latest: Form 483, Aug 10, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-10 | 483 Form 483 | Horsham, Pennsylvania | 6 | $99 |
| 2020-09-15 | Close-out Close-out letter | Warrington, Pennsylvania | — | $99 |
| 2020-09-15 | Warning letter Warning letter | Warrington, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 3003734940 · most recent document Aug 10, 2023
About Coupler Enterprises
How many FDA Form 483s has Coupler Enterprises received?
FDA Intel has 1 Form 483 on file for Coupler Enterprises; the most recent is dated Aug 10, 2023.
When was Coupler Enterprises last inspected by FDA?
The most recent FDA inspection document on file for Coupler Enterprises is a Form 483 dated Aug 10, 2023, for the site in Horsham, Pennsylvania.
What did FDA cite at Coupler Enterprises?
The regulations cited most in the observations on file for Coupler Enterprises are 21 CFR 211.122(g)(3) (Materials examination and usage criteria), 1 time; 21 CFR 211.130(e) (Packaging and labeling operations), 1 time; 21 CFR 211.170(b) (Reserve samples), 1 time.
Has Coupler Enterprises received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Coupler Enterprises; the most recent is dated Sep 15, 2020.