RK Pharma Inc.
Form 483 issued May 31, 2024 · Pearl River, New York
- Inspection
- May 31, 2024
- Investigators
- Brandy N. Lepage· Ruben C. Quintana
- Observations
- 5
- Pages
- 7
- FEI number
- 3014926340
In short: On May 31, 2024, FDA issued a Form 483 with 5 observations to RK Pharma Inc. in Pearl River, New York (FEI 3014926340) after an inspection that ran May 31, 2024. The investigators were Brandy N. Lepage and Ruben C. Quintana. Most observations concern facilities & equipment and laboratory controls.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RK Pharma Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected RK Pharma Inc.?
Brandy N. Lepage and Ruben C. Quintana are named on this Form 483, for the inspection of May 31, 2024. Each investigator has a profile showing what they cite most.
When was RK Pharma Inc. inspected by FDA?
The inspection ran May 31, 2024, and the Form 483 is dated May 31, 2024.
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.