EUGIA Pharma Specialities Limited
Form 483 issued March 6, 2018 · Bhiwadi, India
- Inspection
- Feb 26 – Mar 6, 2018
- Investigators
- Anastasia M. Shields· Carrie A. Hughes
- Observations
- 2
- Pages
- 3
- FEI number
- 3009883410
In short: On March 6, 2018, FDA issued a Form 483 with 2 observations to EUGIA Pharma Specialities Limited in Bhiwadi, India (FEI 3009883410) after an inspection that ran Feb 26 – Mar 6, 2018. The investigators were Anastasia M. Shields and Carrie A. Hughes. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100(a) (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at EUGIA Pharma Specialities Limited?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected EUGIA Pharma Specialities Limited?
Anastasia M. Shields and Carrie A. Hughes are named on this Form 483, for the inspection of Feb 26 – Mar 6, 2018. Each investigator has a profile showing what they cite most.
When was EUGIA Pharma Specialities Limited inspected by FDA?
The inspection ran Feb 26 – Mar 6, 2018, and the Form 483 is dated March 6, 2018.
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.