Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-12-17.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Nov 2021 – 17 Dec 2021 | Human Drugs | 483 | View 483 → |
| 16 Jul 2019 – 1 Aug 2019 | Human Drugs | 483 | View 483 → |
| 7 Feb 2017 – 1 Mar 2017 | Human Drugs | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Dec 2021
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Sangeeta M Khurana, Kenneth O Gee
17 Dec 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Sangeeta M Khurana, Kenneth O Gee
17 Dec 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Sangeeta M Khurana, Kenneth O Gee
17 Dec 2021
21 CFR 211.42(b)
Product flow through building is inadequate
Cited by Sangeeta M Khurana, Kenneth O Gee
Investigators
FDA investigators tied to this site in the record.
Sangeeta M Khurana1 insp.
Kenneth O Gee1 insp.
Bryan L Mcguckin1 insp.
Tracy K Li1 insp.
Gerard P De Leon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind RAM Pharma, Inc's 3 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