AACE Pharmaceuticals, Inc
Form 483 issued August 10, 2020 · FAIRFIELD, New Jersey
- Inspection
- Aug 4 – Aug 10, 2020
- Investigator
- Saleem A. Akhtar
- Observations
- 3
- Pages
- 4
- FEI number
- 3013433273
In short: On August 10, 2020, FDA issued a Form 483 with 3 observations to AACE Pharmaceuticals, Inc in FAIRFIELD, New Jersey (FEI 3013433273) after an inspection that ran Aug 4 – Aug 10, 2020. The investigator was Saleem A. Akhtar. Most observations concern laboratory controls and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Equipment surfaces that contact in-process materials and drug products are reactive, additive or absorptive so as…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
Established laboratory control mechanisms are not documented at…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.65(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AACE Pharmaceuticals, Inc?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected AACE Pharmaceuticals, Inc?
Saleem A. Akhtar is named on this Form 483, for the inspection of Aug 4 – Aug 10, 2020. Each investigator has a profile showing what they cite most.
When was AACE Pharmaceuticals, Inc inspected by FDA?
The inspection ran Aug 4 – Aug 10, 2020, and the Form 483 is dated August 10, 2020.
How do I get the full Form 483 for AACE Pharmaceuticals, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.