AACE Pharmaceuticals, Inc
Form 483 issued November 22, 2024 · Fairfield, New Jersey
- Inspection
- Nov 12 – Nov 22, 2024
- Investigators
- Armen H. Youssoufian· Jonathan G. Matrisciano
- Observations
- 4
- Pages
- 24
- FEI number
- 3013433273
In short: On November 22, 2024, FDA issued a Form 483 with 4 observations to AACE Pharmaceuticals, Inc in Fairfield, New Jersey (FEI 3013433273) after an inspection that ran Nov 12 – Nov 22, 2024. The investigators were Armen H. Youssoufian and Jonathan G. Matrisciano. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to approve and…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
- 03
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Armen H. Youssoufian
9 documents · 2023–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmAACE Pharmaceuticals, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AACE Pharmaceuticals, Inc?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected AACE Pharmaceuticals, Inc?
Armen H. Youssoufian and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Nov 12 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was AACE Pharmaceuticals, Inc inspected by FDA?
The inspection ran Nov 12 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for AACE Pharmaceuticals, Inc?
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