AACE Pharmaceuticals, Inc
FDA inspection history across 2 sites, 2020 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2020: one Form 483; 2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at FAIRFIELD, New Jersey.
- 2024–25One Form 483 and one warning letter, at Fairfield, New Jersey.
- 2024The longest 483 on file: 4 observations over 24 pages at Fairfield, New Jersey.
Cited most
Across all AACE Pharmaceuticals observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.194(a)(4)Laboratory records1
- 21 CFR 211.58Maintenance1
- 21 CFR 211.65(a)Equipment construction1
The complete AACE Pharmaceuticals 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
Fairfield, New Jersey
One warning letter and one Form 483 · 2024 to 2025 · 4 observations
Latest: Warning letter, May 13, 2025 →FAIRFIELD, New Jersey
One Form 483 · 2020 · 3 observations
Latest: Form 483, Aug 10, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-13 | Warning letter Warning letter | Fairfield, New Jersey | — | $99 |
| 2024-11-22 | 483 Form 483 | Fairfield, New Jersey | 4 | $99 |
| 2020-08-10 | 483 Form 483 | FAIRFIELD, New Jersey | 3 | $99 |
Investigators on these documents
Armen H. Youssoufian (1)Jonathan G. Matrisciano (1)Saleem A. Akhtar (1)
FEI number 3013433273 · most recent document May 13, 2025
About AACE Pharmaceuticals, Inc
How many FDA Form 483s has AACE Pharmaceuticals, Inc received?
FDA Intel has 2 Form 483s on file for AACE Pharmaceuticals, Inc; the most recent is dated Nov 22, 2024.
When was AACE Pharmaceuticals, Inc last inspected by FDA?
The most recent FDA inspection document on file for AACE Pharmaceuticals, Inc is a Form 483 dated Nov 22, 2024, for the site in Fairfield, New Jersey.
What did FDA cite at AACE Pharmaceuticals, Inc?
The regulations cited most in the observations on file for AACE Pharmaceuticals, Inc are 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.194(a)(4) (Laboratory records), 1 time.
Has AACE Pharmaceuticals, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for AACE Pharmaceuticals, Inc; the most recent is dated May 13, 2025.