Eugia SEZ Private Limited
Form 483 issued May 4, 2018 · Mahabubnagar, India
- Inspection
- Apr 26 – May 4, 2018
- Investigator
- Niketa Patel
- Observations
- 3
- Pages
- 5
- FEI number
- 3011905047
In short: On May 4, 2018, FDA issued a Form 483 with 3 observations to Eugia SEZ Private Limited in Mahabubnagar, Telangana (FEI 3011905047) after an inspection that ran Apr 26 – May 4, 2018. The investigator was Niketa Patel. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Employees are not given training in the particular operations they perform as…
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia SEZ Private Limited?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Eugia SEZ Private Limited?
Niketa Patel is named on this Form 483, for the inspection of Apr 26 – May 4, 2018. Each investigator has a profile showing what they cite most.
When was Eugia SEZ Private Limited inspected by FDA?
The inspection ran Apr 26 – May 4, 2018, and the Form 483 is dated May 4, 2018.
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.