Rxhomeo Private Limited
Form 483 issued February 1, 2019 · Hyderabad, India
- Inspection
- Jan 28 – Feb 1, 2019
- Investigator
- Nadeem I. Chaudhry
- Observations
- 10
- Pages
- 7
- FEI number
- 3005269310
In short: On February 1, 2019, FDA issued a Form 483 with 10 observations to Rxhomeo Private Limited in Hyderabad, Telangana (FEI 3005269310) after an inspection that ran Jan 28 – Feb 1, 2019. The investigator was Nadeem I. Chaudhry. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and materials account for 6 of 10 observations.
Most cited: 21 CFR 211.188 (2×) · 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
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Component containers dispensed to manufacturing are deficiently examined by a second person in that the component…
This inspection in context
Nadeem I. Chaudhry
6 documents · 2010–2020
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in India.
The firmRxhomeo 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 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rxhomeo Private Limited?
FDA listed 10 observations on this Form 483, mostly about production, materials and laboratory controls. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Rxhomeo Private Limited?
Nadeem I. Chaudhry is named on this Form 483, for the inspection of Jan 28 – Feb 1, 2019. Each investigator has a profile showing what they cite most.
When was Rxhomeo Private Limited inspected by FDA?
The inspection ran Jan 28 – Feb 1, 2019, and the Form 483 is dated February 1, 2019.
How do I get the full Form 483 for Rxhomeo 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.