Aspire Pharmaceuticals Inc.
FDA inspection history in Somerset, New Jersey, 2022 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2022: one warning letter and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Two Form 483s and one warning letter, at Somerset, New Jersey.
- 2022The longest 483 on file: 16 observations over 25 pages at Somerset, New Jersey.
Cited most
Across all Aspire Pharmaceuticals observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 111.105What must quality control personnel do?1
- 21 CFR 111.113What quality control operations are required for a material review and disposition decision?1
The complete Aspire 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
Somerset, New Jersey
Two Form 483s and one warning letter · 2022 to 2023 · 17 observations
Latest: Form 483, Jul 14, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-14 | 483 Form 483 | Somerset, New Jersey | 1 | $99 |
| 2022-11-22 | Warning letter Warning letter | Somerset, New Jersey | — | $99 |
| 2022-02-03 | 483 Form 483 | Somerset, New Jersey | 16 | $99 |
Investigators on these documents
Annet R. Rajan (2)Charlotte P. Chang (2)Jessica M. Monteiro (1)Justin A. Boyd (1)Karen A. Spencer (1)Lata Mathew (1)Robin P. Mathew (1)Seereverse Karen A. Spencer (1)
FEI number 3003159106 · most recent document Jul 14, 2023
About Aspire Pharmaceuticals Inc.
How many FDA Form 483s has Aspire Pharmaceuticals Inc. received?
FDA Intel has 2 Form 483s on file for Aspire Pharmaceuticals Inc.; the most recent is dated Jul 14, 2023.
When was Aspire Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Aspire Pharmaceuticals Inc. is a Form 483 dated Jul 14, 2023, for the site in Somerset, New Jersey.
What did FDA cite at Aspire Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Aspire Pharmaceuticals Inc. are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.194 (Laboratory records), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has Aspire Pharmaceuticals Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Aspire Pharmaceuticals Inc.; the most recent is dated Nov 22, 2022.