EUGIA Pharma Specialities Limited
Form 483 issued May 3, 2024 · Bhiwadi, India
- Inspection
- Apr 25 – May 3, 2024
- Investigators
- Anastasia M. Shields· Justin A. Boyd· Vaishali J. Patel
- Observations
- 7
- Pages
- 14
- FEI number
- 3009883410
In short: On May 3, 2024, FDA issued a Form 483 with 7 observations to EUGIA Pharma Specialities Limited in Bhiwadi, RJ (FEI 3009883410) after an inspection that ran Apr 25 – May 3, 2024. The investigators were Anastasia M. Shields, Justin A. Boyd and Vaishali J. Patel. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.113(b) (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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
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 4 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 7 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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?
Anastasia M. Shields, Justin A. Boyd and Vaishali J. Patel are named on this Form 483, for the inspection of Apr 25 – May 3, 2024. Each investigator has a profile showing what they cite most.
When was EUGIA Pharma Specialities Limited inspected by FDA?
The inspection ran Apr 25 – May 3, 2024, and the Form 483 is dated May 3, 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.