Gland Pharma Limited
Form 483 issued November 1, 2019 · Visakhapatnam, India
- Inspection
- Oct 24 – Nov 1, 2019
- Investigator
- Junho Pak
- Observations
- 2
- Pages
- 3
- FEI number
- 3009056604
In short: On November 1, 2019, FDA issued a Form 483 with 2 observations to Gland Pharma Limited in Visakhapatnam, Andhra Pradesh (FEI 3009056604) after an inspection that ran Oct 24 – Nov 1, 2019. The investigator was Junho Pak. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmGland Pharma Limited history
All 3 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 Gland Pharma Limited?
FDA listed 2 observations on this Form 483, mostly about production 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 Gland Pharma Limited?
Junho Pak is named on this Form 483, for the inspection of Oct 24 – Nov 1, 2019. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Oct 24 – Nov 1, 2019, and the Form 483 is dated November 1, 2019.
How do I get the full Form 483 for Gland Pharma 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.