Matrix Pharmacorp Private Limited
Form 483 issued September 17, 2022 · Patancheru, India
- Investigator
- Pratik S. Upadhyay
- Observations
- 4
- Pages
- 5
- FEI number
- 3003227156
In short: On September 17, 2022, FDA issued a Form 483 with 4 observations to Matrix Pharmacorp Private Limited in Patancheru, Telangana (FEI 3003227156). The investigator was Pratik S. Upadhyay. 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 3 of 4 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(REPEAT OBSERVATION) Failure to validate all laboratory tests relevant to the production and analysis of…
- 02
Equipment and utensils are not cleaned, maintained, and sanitized at an appropriate interval to prevent contamination…
- 03
The control procedure SOP-000460133, entitled, “Notification of Critical Quality Events”, Version 7.0 is inadequate. The procedure…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
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 3 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 4 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?
Pratik S. Upadhyay is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Matrix Pharmacorp Private Limited inspected by FDA?
This Form 483 is dated September 17, 2022.
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.