Aspire Pharmaceuticals Inc.
Form 483 issued February 3, 2022 · Somerset, New Jersey
- Investigators
- Annet R. Rajan· Charlotte P. Chang· Justin A. Boyd
- Observations
- 16
- Pages
- 25
- FEI number
- 3003159106
In short: On February 3, 2022, FDA issued a Form 483 with 16 observations to Aspire Pharmaceuticals Inc. in Somerset, New Jersey (FEI 3003159106). The investigators were Annet R. Rajan, Charlotte P. Chang, Justin A. Boyd, Karen A. Spencer, Lata Mathew and Seereverse Karen A. Spencer. Most observations concern dietary supplement CGMP and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Dietary supplement CGMP and laboratory controls account for 12 of 16 observations.
Most cited: 21 CFR 211.160 (2×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Established test procedures and laboratory control mechanisms are not followed and documented at…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
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 16 observations on this Form 483, mostly about dietary supplement CGMP, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Aspire Pharmaceuticals Inc.?
Annet R. Rajan, Charlotte P. Chang, Justin A. Boyd, Karen A. Spencer, Lata Mathew and Seereverse Karen A. Spencer are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Aspire Pharmaceuticals Inc. inspected by FDA?
This Form 483 is dated February 3, 2022.
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.