RAM Pharma, Inc.
FDA inspection history in Idaho Falls, Idaho, 2017 to 2021
- 3
- Form 483s
- 1
- Response
Every document, by year
- Form 483
- Response
2017: one 483 response and one Form 483; 2019: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–21Three Form 483s and one 483 response, at Idaho Falls, Idaho.
- 2017The longest 483 on file: 13 observations over 13 pages at Idaho Falls, Idaho.
Cited most
Across all RAM Pharma observations on file
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.160(b)General requirements1
The complete RAM Pharma file.
All 4 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
Idaho Falls, Idaho
Three Form 483s and one 483 response · 2017 to 2021 · 27 observations
Latest: Form 483, Dec 17, 2021 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-17 | 483 Form 483 | Idaho Falls, Idaho | 7 | $99 |
| 2019-08-01 | 483 Form 483 | Idaho Falls, Idaho | 7 | $99 |
| 2017-03-22 | Response 483 response | Idaho Falls, Idaho | — | $199 |
| 2017-02-07 | 483 Form 483 | Idaho Falls, Idaho | 13 | $99 |
Investigators on these documents
Gerard P. De Leon (2)Gary C. Pecic (1)Kenneth O. Gee (1)Lisa T. Michel (1)Sangeeta M. Khurana (1)Tracy K. Li (1)Bryan L. McGuckin (1)Tracy K. Ll (1)
FEI number 3012465222 · most recent document Dec 17, 2021
About RAM Pharma, Inc.
How many FDA Form 483s has RAM Pharma, Inc. received?
FDA Intel has 3 Form 483s on file for RAM Pharma, Inc.; the most recent is dated Dec 17, 2021.
When was RAM Pharma, Inc. last inspected by FDA?
The most recent FDA inspection document on file for RAM Pharma, Inc. is a Form 483 dated Dec 17, 2021, for the site in Idaho Falls, Idaho.
What did FDA cite at RAM Pharma, Inc.?
The regulations cited most in the observations on file for RAM Pharma, Inc. are 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.165 (Testing and release for distribution), 2 times.