Eugia SEZ Private Limited
Form 483 issued March 1, 2019 · Mahabubnagar District, India
- Inspection
- Feb 22 – Mar 1, 2019
- Investigators
- Jose E. Melendez· Linda F. Murphy· Walden H. Lee
- Observations
- 2
- Pages
- 15
- FEI number
- 3011905047
In short: On March 1, 2019, FDA issued a Form 483 with 2 observations to Eugia SEZ Private Limited in Mahabubnagar District, India (FEI 3011905047) after an inspection that ran Feb 22 – Mar 1, 2019. The investigators were Jose E. Melendez, Linda F. Murphy and Walden H. Lee. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.110(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmEugia SEZ 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia SEZ Private Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Eugia SEZ Private Limited?
Jose E. Melendez, Linda F. Murphy and Walden H. Lee are named on this Form 483, for the inspection of Feb 22 – Mar 1, 2019. Each investigator has a profile showing what they cite most.
When was Eugia SEZ Private Limited inspected by FDA?
The inspection ran Feb 22 – Mar 1, 2019, and the Form 483 is dated March 1, 2019.
How do I get the full Form 483 for Eugia SEZ 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.