EUGIA Pharma Specialities Limited
Form 483 issued August 28, 2019 · Medchal-Malkajgiri, India
- Inspection
- Aug 19 – Aug 28, 2019
- Investigator
- Roger F. Zabinski
- Observations
- 3
- Pages
- 2
- FEI number
- 3011960448
In short: On August 28, 2019, FDA issued a Form 483 with 3 observations to EUGIA Pharma Specialities Limited in Medchal-Malkajgiri, Telangana (FEI 3011960448) after an inspection that ran Aug 19 – Aug 28, 2019. The investigator was Roger F. Zabinski. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product production and control records, are not reviewed by the quality control unit to determine…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
- 03
Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmEUGIA Pharma Specialities 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at EUGIA Pharma Specialities Limited?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected EUGIA Pharma Specialities Limited?
Roger F. Zabinski is named on this Form 483, for the inspection of Aug 19 – Aug 28, 2019. Each investigator has a profile showing what they cite most.
When was EUGIA Pharma Specialities Limited inspected by FDA?
The inspection ran Aug 19 – Aug 28, 2019, and the Form 483 is dated August 28, 2019.
How do I get the full Form 483 for EUGIA Pharma Specialities 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.