RK Pharma Inc.
Form 483 issued August 12, 2022 · Pearl River, New York
- Inspection
- Aug 3 – Aug 12, 2022
- Investigator
- Samir C. Gala
- Observations
- 4
- Pages
- 5
- FEI number
- 3014926340
In short: On August 12, 2022, FDA issued a Form 483 with 4 observations to RK Pharma Inc. in Pearl River, New York (FEI 3014926340) after an inspection that ran Aug 3 – Aug 12, 2022. The investigator was Samir C. Gala. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 3 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Samir C. Gala
10 documents · 2020–2024
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Connecticut.
The firmRK Pharma Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RK Pharma Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected RK Pharma Inc.?
Samir C. Gala is named on this Form 483, for the inspection of Aug 3 – Aug 12, 2022. Each investigator has a profile showing what they cite most.
When was RK Pharma Inc. inspected by FDA?
The inspection ran Aug 3 – Aug 12, 2022, and the Form 483 is dated August 12, 2022.
How do I get the full Form 483 for RK Pharma 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.