Repro-Med Systems, Inc.
FDA inspection history in Chester, New York, 2016 to 2017
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2016: one Form 483 and one warning letter; 2017: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One Form 483, one warning letter and one close-out letter, at Chester, New York.
Cited most
Across all Repro-Med Systems observations on file
- 21 CFR 820.30(f)Design controls2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 806.10(a)(1)Reports of corrections and removals1
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
The complete Repro-Med Systems 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
Chester, New York
One close-out letter, one Form 483 and one warning letter · 2016 to 2017 · 8 observations
Latest: Close-out, Nov 20, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-11-20 | Close-out Close-out letter | Chester, New York | — | $99 |
| 2016-12-16 | 483 Form 483 | Chester, New York | 8 | $99 |
| 2016-02-26 | Warning letter Warning letter | Chester, New York | — | $99 |
Investigators on these documents
FEI number 1318360 · most recent document Nov 20, 2017
About Repro-Med Systems, Inc.
How many FDA Form 483s has Repro-Med Systems, Inc. received?
FDA Intel has 1 Form 483 on file for Repro-Med Systems, Inc.; the most recent is dated Dec 16, 2016.
When was Repro-Med Systems, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Repro-Med Systems, Inc. is a Form 483 dated Dec 16, 2016, for the site in Chester, New York.
What did FDA cite at Repro-Med Systems, Inc.?
The regulations cited most in the observations on file for Repro-Med Systems, Inc. are 21 CFR 820.30(f) (Design controls), 2 times; 21 CFR 820.90(a) (Nonconforming product), 2 times; 21 CFR 806.10(a)(1) (Reports of corrections and removals), 1 time.
Has Repro-Med Systems, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Repro-Med Systems, Inc.; the most recent is dated Feb 26, 2016.