Matrix Pharmacorp Private Limited
Form 483 issued February 28, 2020 · Patancheru, India
- Inspection
- Feb 24 – Feb 28, 2020
- Investigators
- Christopher Keating· Tomika L. Bivens
- Observations
- 5
- Pages
- 3
- FEI number
- 3003227156
In short: On February 28, 2020, FDA issued a Form 483 with 5 observations to Matrix Pharmacorp Private Limited in Patancheru, Telangana (FEI 3003227156) after an inspection that ran Feb 24 – Feb 28, 2020. The investigators were Christopher Keating and Tomika L. Bivens. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and facilities & equipment account for 3 of 5 observations.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to perform an appropriate cleaning validation for the APIs and API intermediates…
- 02
You have no written established system governing the use, transport, storage, and cleaning of the non-dedicated…
- 03
Your analytical procedures for incoming raw material inspection…
- 04
Failure to validate all laboratory tests relevant to the production and analysis of…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMatrix Pharmacorp Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Matrix Pharmacorp Private Limited?
FDA listed 5 observations on this Form 483, mostly about materials, facilities & equipment and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Matrix Pharmacorp Private Limited?
Christopher Keating and Tomika L. Bivens are named on this Form 483, for the inspection of Feb 24 – Feb 28, 2020. Each investigator has a profile showing what they cite most.
When was Matrix Pharmacorp Private Limited inspected by FDA?
The inspection ran Feb 24 – Feb 28, 2020, and the Form 483 is dated February 28, 2020.
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.