Matrix Pharmacorp Private Limited
FDA inspection history across 2 sites, 2020 to 2022
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2020: one warning letter and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–22Two Form 483s and one warning letter, at Canonsburg, Pennsylvania and Patancheru, India.
- 2020The longest 483 on file: 5 observations over 3 pages at Patancheru, India.
Cited most
Across all Matrix Pharmacorp Private Limited observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
The complete Matrix Pharmacorp Private Limited 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
Patancheru, India
Two Form 483s · 2020 to 2022 · 9 observations
Latest: Form 483, Sep 17, 2022 →Canonsburg, Pennsylvania
One warning letter · 2020
Latest: Warning letter, Aug 20, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-17 | 483 Form 483 | Patancheru, India | 4 | $99 |
| 2020-08-20 | Warning letter Warning letter | Canonsburg, Pennsylvania | — | $99 |
| 2020-02-28 | 483 Form 483 | Patancheru, India | 5 | $99 |
Investigators on these documents
Christopher Keating (1)Pratik S. Upadhyay (1)Tomika L. Bivens (1)
FEI number 3003227156 · most recent document Sep 17, 2022
About Matrix Pharmacorp Private Limited
How many FDA Form 483s has Matrix Pharmacorp Private Limited received?
FDA Intel has 2 Form 483s on file for Matrix Pharmacorp Private Limited; the most recent is dated Sep 17, 2022.
When was Matrix Pharmacorp Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Matrix Pharmacorp Private Limited is a Form 483 dated Sep 17, 2022, for the site in Patancheru, India.
What did FDA cite at Matrix Pharmacorp Private Limited?
The regulations cited most in the observations on file for Matrix Pharmacorp Private Limited are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Matrix Pharmacorp Private Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Matrix Pharmacorp Private Limited; the most recent is dated Aug 20, 2020.