ECI Pharmaceuticals LLC
FDA inspection history across 2 sites, 2015 to 2023
- 3
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2015: one Form 483; 2016: one Form 483; 2022: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16Two Form 483s, at Ft. Lauderdale, Florida.
- 2016The longest 483 on file: 6 observations over 7 pages at Ft. Lauderdale, Florida.
- 2022–23One warning letter and one Form 483, at Fort Lauderdale, Florida and Ft. Lauderdale, Florida.
Cited most
Across all ECI Pharmaceuticals observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 314.80(b)Postmarketing reporting of adverse drug experiences2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.186Master production and control records1
The complete ECI Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Ft. Lauderdale, Florida
Three Form 483s and one close-out letter · 2015 to 2023 · 13 observations
Latest: Form 483, Jan 27, 2023 →Fort Lauderdale, Florida
One warning letter · 2022
Latest: Warning letter, Feb 3, 2022 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-27 | 483 Form 483 | Ft. Lauderdale, Florida | 3 | $99 |
| 2022-02-03 | Warning letter Warning letter | Fort Lauderdale, Florida | — | $99 |
| 2016-11-18 | 483 Form 483 | Ft. Lauderdale, Florida | 6 | $99 |
| 2015-02-27 | 483 Form 483 | Ft. Lauderdale, Florida | 4 | $99 |
| Undated | Close-out Close-out letter | Ft. Lauderdale, Florida | — | $99 |
Investigators on these documents
FEI number 3008798439 · most recent document Jan 27, 2023
About ECI Pharmaceuticals LLC
How many FDA Form 483s has ECI Pharmaceuticals LLC received?
FDA Intel has 3 Form 483s on file for ECI Pharmaceuticals LLC; the most recent is dated Jan 27, 2023.
When was ECI Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for ECI Pharmaceuticals LLC is a Form 483 dated Jan 27, 2023, for the site in Ft. Lauderdale, Florida.
What did FDA cite at ECI Pharmaceuticals LLC?
The regulations cited most in the observations on file for ECI Pharmaceuticals LLC are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 314.80(b) (Postmarketing reporting of adverse drug experiences), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has ECI Pharmaceuticals LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for ECI Pharmaceuticals LLC; the most recent is dated Feb 3, 2022.