Aspire Pharmaceuticals Inc.
Form 483 issued July 14, 2023 · Somerset, New Jersey
- Inspection
- Jun 28 – Jul 14, 2023
- Investigators
- Annet R. Rajan· Charlotte P. Chang· Jessica M. Monteiro
- Observations
- 1
- Pages
- 3
- FEI number
- 3003159106
In short: On July 14, 2023, FDA issued a Form 483 with 1 observation to Aspire Pharmaceuticals Inc. in Somerset, New Jersey (FEI 3003159106) after an inspection that ran Jun 28 – Jul 14, 2023. The investigators were Annet R. Rajan, Charlotte P. Chang, Jessica M. Monteiro and Robin P. Mathew. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Repeat Observation) Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmAspire 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aspire Pharmaceuticals Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Aspire Pharmaceuticals Inc.?
Annet R. Rajan, Charlotte P. Chang, Jessica M. Monteiro and Robin P. Mathew are named on this Form 483, for the inspection of Jun 28 – Jul 14, 2023. Each investigator has a profile showing what they cite most.
When was Aspire Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jun 28 – Jul 14, 2023, and the Form 483 is dated July 14, 2023.
How do I get the full Form 483 for Aspire 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.