US Pharmaceuticals Inc
FDA inspection history across 2 sites, 2018 to 2025
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2018: one Form 483; 2019: one close-out letter; 2020: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–20Two Form 483s and one close-out letter, at Belleville, New Jersey.
- 2018The longest 483 on file: 6 observations over 8 pages at Belleville, New Jersey.
- 2025One warning letter, at South Plainfield, New Jersey.
Cited most
Across all US Pharmaceuticals observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.160(b)(1)General requirements1
- 21 CFR 211.186(a)Master production and control records1
The complete US Pharmaceuticals file.
All 4 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
Belleville, New Jersey
Two Form 483s and one close-out letter · 2018 to 2020 · 10 observations
Latest: Form 483, Oct 16, 2020 →South Plainfield, New Jersey
One warning letter · 2025
Latest: Warning letter, Dec 19, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-19 | Warning letter Warning letter | South Plainfield, New Jersey | — | $99 |
| 2020-10-16 | 483 Form 483 | Belleville, New Jersey | 4 | $99 |
| 2019-06-06 | Close-out Close-out letter | Belleville, New Jersey | — | $99 |
| 2018-12-18 | 483 Form 483 | Belleville, New Jersey | 6 | $99 |
Investigators on these documents
FEI number 3008275696 · most recent document Dec 19, 2025
About US Pharmaceuticals Inc
How many FDA Form 483s has US Pharmaceuticals Inc received?
FDA Intel has 2 Form 483s on file for US Pharmaceuticals Inc; the most recent is dated Oct 16, 2020.
When was US Pharmaceuticals Inc last inspected by FDA?
The most recent FDA inspection document on file for US Pharmaceuticals Inc is a Form 483 dated Oct 16, 2020, for the site in Belleville, New Jersey.
What did FDA cite at US Pharmaceuticals Inc?
The regulations cited most in the observations on file for US Pharmaceuticals Inc are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.125(a) (Labeling issuance), 1 time.
Has US Pharmaceuticals Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for US Pharmaceuticals Inc; the most recent is dated Dec 19, 2025.