Gland Pharma Limited
Form 483 issued March 17, 2015 · Hyderabad, India
- Inspection
- Mar 9 – Mar 17, 2015
- Investigator
- Carla J. Lundi
- Observations
- 2
- Pages
- 1
- FEI number
- 3002647489
In short: On March 17, 2015, FDA issued a Form 483 with 2 observations to Gland Pharma Limited in Hyderabad, Telangana (FEI 3002647489) after an inspection that ran Mar 9 – Mar 17, 2015. The investigator was Carla J. Lundi. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The procedures for the annual quality standards record evaluation are deficient in that they do not…
- 02
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Carla J. Lundi
9 documents · 2009–2021
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmGland Pharma Limited history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180
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 quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Gland Pharma Limited?
Carla J. Lundi is named on this Form 483, for the inspection of Mar 9 – Mar 17, 2015. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Mar 9 – Mar 17, 2015, and the Form 483 is dated March 17, 2015.
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.