RemedyRepack Inc
FDA inspection history in Indiana, Pennsylvania, 2015 to 2023
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2015: one Form 483 and one warning letter; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483 and one warning letter, at Indiana, Pennsylvania.
- 2023One warning letter, at Indiana, Pennsylvania.
Cited most
Across all RemedyRepack observations on file
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.125(f)Labeling issuance1
- 21 CFR 211.130Packaging and labeling operations1
- 21 CFR 211.170(b)(1)Reserve samples1
The complete RemedyRepack 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
Indiana, Pennsylvania
Two warning letters and one Form 483 · 2015 to 2023 · 10 observations
Latest: Warning letter, May 11, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-11 | Warning letter Warning letter | Indiana, Pennsylvania | — | $99 |
| 2015-11-23 | 483 Form 483 | Indiana, Pennsylvania | 10 | $99 |
| 2015-03-31 | Warning letter Warning letter | Indiana, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 3005841768 · most recent document May 11, 2023
About RemedyRepack Inc
How many FDA Form 483s has RemedyRepack Inc received?
FDA Intel has 1 Form 483 on file for RemedyRepack Inc; the most recent is dated Nov 23, 2015.
When was RemedyRepack Inc last inspected by FDA?
The most recent FDA inspection document on file for RemedyRepack Inc is a Form 483 dated Nov 23, 2015, for the site in Indiana, Pennsylvania.
What did FDA cite at RemedyRepack Inc?
The regulations cited most in the observations on file for RemedyRepack Inc are 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.125(f) (Labeling issuance), 1 time.
Has RemedyRepack Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for RemedyRepack Inc; the most recent is dated May 11, 2023.