Gland Pharma Limited
Form 483 issued August 25, 2022 · Hyderabad, India
- Inspection
- Aug 22 – Aug 25, 2022
- Investigator
- Joshua J. Silvestri
- Observations
- 1
- Pages
- 4
- FEI number
- 3002647489
In short: On August 25, 2022, FDA issued a Form 483 with 1 observation to Gland Pharma Limited in Hyderabad, Telangana (FEI 3002647489) after an inspection that ran Aug 22 – Aug 25, 2022. The investigator was Joshua J. Silvestri. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
This inspection in context
Joshua J. Silvestri
8 documents · 2019–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Georgia.
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 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gland Pharma Limited?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Gland Pharma Limited?
Joshua J. Silvestri is named on this Form 483, for the inspection of Aug 22 – Aug 25, 2022. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Aug 22 – Aug 25, 2022, and the Form 483 is dated August 25, 2022.
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.