Eugia Pharma Specialities Limited
Form 483 issued November 13, 2019 · Sangareddy, India
- Inspection
- Nov 4 – Nov 13, 2019
- Investigators
- Dipesh K. Shah· Freddy Ortiz Colon· June P. Page
- Observations
- 14
- Pages
- 37
- FEI number
- 3008461619
In short: On November 13, 2019, FDA issued a Form 483 with 14 observations to Eugia Pharma Specialities Limited in Sangareddy, Telangana (FEI 3008461619) after an inspection that ran Nov 4 – Nov 13, 2019. The investigators were Dipesh K. Shah, Freddy Ortiz Colon, June P. Page, Marie B. Buen-Bigornia and Thomas J. Arista. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.42 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
SIPLOVEEIS/ SIGNATURE are move 502307 India Aseptic processing areas are deficient regarding systems for maintaining any…
- 04
Established test procedures are…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmEugia Pharma Specialities Limited history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia Pharma Specialities Limited?
FDA listed 14 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Eugia Pharma Specialities Limited?
Dipesh K. Shah, Freddy Ortiz Colon, June P. Page, Marie B. Buen-Bigornia and Thomas J. Arista are named on this Form 483, for the inspection of Nov 4 – Nov 13, 2019. Each investigator has a profile showing what they cite most.
When was Eugia Pharma Specialities Limited inspected by FDA?
The inspection ran Nov 4 – Nov 13, 2019, and the Form 483 is dated November 13, 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.