Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-27.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 27 Mar 2026 | Human Drugs | 483 | On file |
| 18 Aug 2025 – 28 Aug 2025 | Human Drugs | 483 | On file |
| 20 May 2024 – 31 May 2024 | Human Drugs | 483 | View 483 → |
| 3 Aug 2022 – 12 Aug 2022 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 May 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Brandy N Lepage, Ruben C Quintana
31 May 2024
21 CFR 211.184(e)
Records of disposition of rejected material
Cited by Brandy N Lepage, Ruben C Quintana
31 May 2024
21 CFR 211.63
Equipment Design, Size and Location
Cited by Brandy N Lepage, Ruben C Quintana
31 May 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Brandy N Lepage, Ruben C Quintana
31 May 2024
21 CFR 211.68(b)
Computer control of master formula records
Cited by Brandy N Lepage, Ruben C Quintana
Investigators
FDA investigators tied to this site in the record.
Lata C Mathew2 insp.
Robin P Mathew1 insp.
Brandy N Lepage1 insp.
Ruben C Quintana1 insp.
Gam S Zamil1 insp.
Mindy M Chou1 insp.
Samir C Gala1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind RK Pharma Inc.'s 4 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat