Replication Medical, Inc
FDA inspection history across 3 sites, 2010 to 2018
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2010: one close-out letter and one warning letter; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One close-out letter and one warning letter, at Silver Spring, Maryland and Cranbury, New Jersey.
- 2018One Form 483, at Monmouth Junction, New Jersey.
Cited most
Across all Replication Medical observations on file
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.181Device master record1
- 21 CFR 820.184Device history record1
- 21 CFR 820.40(a)Document controls1
- 21 CFR 820.70(a)Production and process controls1
The complete Replication Medical file.
All 3 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
Monmouth Junction, New Jersey
One Form 483 · 2018 · 6 observations
Latest: Form 483, Aug 22, 2018 →Silver Spring, Maryland
One close-out letter · 2010
Latest: Close-out, Jul 2, 2010 →Cranbury, New Jersey
One warning letter · 2010
Latest: Warning letter, Jul 2, 2010 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-22 | 483 Form 483 | Monmouth Junction, New Jersey | 6 | $99 |
| 2010-07-02 | Close-out Close-out letter | Silver Spring, Maryland | — | $99 |
| 2010-07-02 | Warning letter Warning letter | Cranbury, New Jersey | — | $99 |
Investigators on these documents
FEI number 3004641714 · most recent document Aug 22, 2018
About Replication Medical, Inc
How many FDA Form 483s has Replication Medical, Inc received?
FDA Intel has 1 Form 483 on file for Replication Medical, Inc; the most recent is dated Aug 22, 2018.
When was Replication Medical, Inc last inspected by FDA?
The most recent FDA inspection document on file for Replication Medical, Inc is a Form 483 dated Aug 22, 2018, for the site in Monmouth Junction, New Jersey.
What did FDA cite at Replication Medical, Inc?
The regulations cited most in the observations on file for Replication Medical, Inc are 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.181 (Device master record), 1 time; 21 CFR 820.184 (Device history record), 1 time.
Has Replication Medical, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Replication Medical, Inc; the most recent is dated Jul 2, 2010.