Sionc Pharmaceuticals Private Limited, Unit II
Form 483 issued February 7, 2020 · Visakhapatnam, India
- Inspection
- Feb 3 – Feb 7, 2020
- Investigator
- Bijoy Panicker
- Observations
- 2
- Pages
- 3
- FEI number
- 3013656125
In short: On February 7, 2020, FDA issued a Form 483 with 2 observations to Sionc Pharmaceuticals Private Limited, Unit II in Visakhapatnam, Andhra Pradesh (FEI 3013656125) after an inspection that ran Feb 3 – Feb 7, 2020. The investigator was Bijoy Panicker. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Written procedures are not followed for cleaning and maintenance of equipment, and procedures fail to include…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmSionc Pharmaceuticals Private Limited, Unit II history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sionc Pharmaceuticals Private Limited, Unit II?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. 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 Sionc Pharmaceuticals Private Limited, Unit II?
Bijoy Panicker is named on this Form 483, for the inspection of Feb 3 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was Sionc Pharmaceuticals Private Limited, Unit II inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
How do I get the full Form 483 for Sionc Pharmaceuticals Private Limited, Unit II?
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.