Health Pharma USA LLC
FDA inspection history in Rahway, New Jersey, 2019 to 2024
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one close-out letter; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One close-out letter, at Rahway, New Jersey.
- 2022–24Two Form 483s, at Rahway, New Jersey.
- 2022The longest 483 on file: 14 observations over 12 pages at Rahway, New Jersey.
Cited most
Across all Health Pharma USA observations on file
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment4
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.188(a)Batch production and control records2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
The complete Health Pharma USA 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
Rahway, New Jersey
Two Form 483s and one close-out letter · 2019 to 2024 · 21 observations
Latest: Form 483, Jul 3, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-03 | 483 Form 483 | Rahway, New Jersey | 7 | $99 |
| 2022-12-20 | 483 Form 483 | Rahway, New Jersey | 14 | $99 |
| 2019-12-18 | Close-out Close-out letter | Rahway, New Jersey | — | $99 |
Investigators on these documents
Andrew O. Ejiofor (1)Annet R. Rajan (1)Nicholas Violand (1)Rose Jean-Mary (1)Suchan Kim (1)Syeda N. Mahazabin (1)
FEI number 3013856804 · most recent document Jul 3, 2024
About Health Pharma USA LLC
How many FDA Form 483s has Health Pharma USA LLC received?
FDA Intel has 2 Form 483s on file for Health Pharma USA LLC; the most recent is dated Jul 3, 2024.
When was Health Pharma USA LLC last inspected by FDA?
The most recent FDA inspection document on file for Health Pharma USA LLC is a Form 483 dated Jul 3, 2024, for the site in Rahway, New Jersey.
What did FDA cite at Health Pharma USA LLC?
The regulations cited most in the observations on file for Health Pharma USA LLC are 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 4 times; 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.166(a) (Stability testing), 2 times.