Sionc Pharmaceuticals Private Limited
Form 483 issued August 2, 2019 · Visakhapatnam, India
- Inspection
- Jul 29 – Aug 2, 2019
- Investigator
- Dipesh K. Shah
- Observations
- 2
- Pages
- 2
- FEI number
- 3008570863
In short: On August 2, 2019, FDA issued a Form 483 with 2 observations to Sionc Pharmaceuticals Private Limited in Visakhapatnam, Andhra Pradesh (FEI 3008570863) after an inspection that ran Jul 29 – Aug 2, 2019. The investigator was Dipesh K. Shah. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibility and procedures applicable to the quality control unit…
- 02
Your firm's cleaning processes validation…
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 firmSionc Pharmaceuticals Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sionc Pharmaceuticals Private Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sionc Pharmaceuticals Private Limited?
Dipesh K. Shah is named on this Form 483, for the inspection of Jul 29 – Aug 2, 2019. Each investigator has a profile showing what they cite most.
When was Sionc Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Jul 29 – Aug 2, 2019, and the Form 483 is dated August 2, 2019.
How do I get the full Form 483 for Sionc Pharmaceuticals Private 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.