Matrix Pharmacorp Private Limited
Form 483 issued December 10, 2018 · Vizianagaram, India
- Inspection
- Dec 3 – Dec 10, 2018
- Investigators
- Darren S. Brown· Nayan J. Patel
- Observations
- 3
- Pages
- 4
- FEI number
- 3002785310
In short: On December 10, 2018, FDA issued a Form 483 with 3 observations to Matrix Pharmacorp Private Limited in Vizianagaram, Andhra Pradesh (FEI 3002785310) after an inspection that ran Dec 3 – Dec 10, 2018. The investigators were Darren S. Brown and Nayan J. Patel. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are inadequate in that they are not conducted to thoroughly evaluate all potential root…
- 02
Buildings and equipment used in the manufacture of intermediates and APIs are not properly maintained, repaired…
- 03
Analytical methods used to determine purity, strength, quality, and identity of drug substances are not the…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmMatrix Pharmacorp Private Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Matrix Pharmacorp Private Limited?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Matrix Pharmacorp Private Limited?
Darren S. Brown and Nayan J. Patel are named on this Form 483, for the inspection of Dec 3 – Dec 10, 2018. Each investigator has a profile showing what they cite most.
When was Matrix Pharmacorp Private Limited inspected by FDA?
The inspection ran Dec 3 – Dec 10, 2018, and the Form 483 is dated December 10, 2018.
How do I get the full Form 483 for Matrix Pharmacorp Private Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.