Matrix Pharmacorp Private Limited
Form 483 issued March 16, 2018 · Hyderabad, India
- Inspection
- Mar 12 – Mar 16, 2018
- Investigator
- Yvins Dezan
- Observations
- 11
- Pages
- 12
- FEI number
- 3004713397
In short: On March 16, 2018, FDA issued a Form 483 with 11 observations to Matrix Pharmacorp Private Limited in Hyderabad, Telangana (FEI 3004713397) after an inspection that ran Mar 12 – Mar 16, 2018. The investigator was Yvins Dezan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 8 of 11 observations.
Most cited: 21 CFR 211.67 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures describing the handling of written and oral complaints related to API…
- 04
Employees engaged in the processing, holding, and testing of a drug product lack the training and…
This inspection in context
Yvins Dezan
27 documents · 2017–2026
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 2 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 11 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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?
Yvins Dezan is named on this Form 483, for the inspection of Mar 12 – Mar 16, 2018. Each investigator has a profile showing what they cite most.
When was Matrix Pharmacorp Private Limited inspected by FDA?
The inspection ran Mar 12 – Mar 16, 2018, and the Form 483 is dated March 16, 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.