RK Pharma Inc.
FDA inspection history in Pearl River, New York, 2022 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s, at Pearl River, New York.
- 2024The longest 483 on file: 5 observations over 7 pages at Pearl River, New York.
Cited most
Across all RK Pharma observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.184(e)Component, drug product container, closure, and labeling records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete RK Pharma file.
All 2 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
Pearl River, New York
Two Form 483s · 2022 to 2024 · 9 observations
Latest: Form 483, May 31, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-31 | 483 Form 483 | Pearl River, New York | 5 | $99 |
| 2022-08-12 | 483 Form 483 | Pearl River, New York | 4 | $99 |
Investigators on these documents
FEI number 3014926340 · most recent document May 31, 2024
About RK Pharma Inc.
How many FDA Form 483s has RK Pharma Inc. received?
FDA Intel has 2 Form 483s on file for RK Pharma Inc.; the most recent is dated May 31, 2024.
When was RK Pharma Inc. last inspected by FDA?
The most recent FDA inspection document on file for RK Pharma Inc. is a Form 483 dated May 31, 2024, for the site in Pearl River, New York.
What did FDA cite at RK Pharma Inc.?
The regulations cited most in the observations on file for RK Pharma Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.