Matrix Pharmacorp Private Limited
Form 483 issued June 5, 2019 · Vizianagaram, India
- Inspection
- May 27 – Jun 5, 2019
- Investigators
- Miguel A. Martinez· Rajiv R. Srivastava
- Observations
- 6
- Pages
- 11
- FEI number
- 3002785310
In short: On June 5, 2019, FDA issued a Form 483 with 6 observations to Matrix Pharmacorp Private Limited in Vizianagaram, Andhra Pradesh (FEI 3002785310) after an inspection that ran May 27 – Jun 5, 2019. The investigators were Miguel A. Martinez and Rajiv R. Srivastava. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 5 of 6 observations.
Most cited: 21 CFR 211.67 (3×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your existing procedures are inadequate to ensure that the materials are handled in a manner that…
- 02
Investigations are inadequate in that the quality unit did not evaluate all potential root causes for…
- 03
Your firm’s cleaning processes for non-dedicated equipment have not been…
- 04
Production equipment is not stored appropriately to prevent contamination or carry-over of a material that would…
This inspection in context
Miguel A. Martinez
16 documents · 2014–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Matrix Pharmacorp Private Limited?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Matrix Pharmacorp Private Limited?
Miguel A. Martinez and Rajiv R. Srivastava are named on this Form 483, for the inspection of May 27 – Jun 5, 2019. Each investigator has a profile showing what they cite most.
When was Matrix Pharmacorp Private Limited inspected by FDA?
The inspection ran May 27 – Jun 5, 2019, and the Form 483 is dated June 5, 2019.
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.