Eugia Pharma Specialities Limited
Form 483 issued February 2, 2024 · Sangareddy, India
- Inspection
- Jan 22 – Feb 2, 2024
- Investigators
- Anastasia M. Shields· Eileen A. Liu· Justin A. Boyd
- Observations
- 9
- Pages
- 26
- FEI number
- 3008461619
In short: On February 2, 2024, FDA issued a Form 483 with 9 observations to Eugia Pharma Specialities Limited in Sangareddy, Telangana (FEI 3008461619) after an inspection that ran Jan 22 – Feb 2, 2024. The investigators were Anastasia M. Shields, Eileen A. Liu and Justin A. Boyd. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 211.113(b) (2×) · 211.100(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia Pharma Specialities Limited?
FDA listed 9 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Eugia Pharma Specialities Limited?
Anastasia M. Shields, Eileen A. Liu and Justin A. Boyd are named on this Form 483, for the inspection of Jan 22 – Feb 2, 2024. Each investigator has a profile showing what they cite most.
When was Eugia Pharma Specialities Limited inspected by FDA?
The inspection ran Jan 22 – Feb 2, 2024, and the Form 483 is dated February 2, 2024.
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.