Gland Pharma Limited
Form 483 issued August 26, 2023 · Hyderabad, India
- Inspection
- Aug 23 – Aug 26, 2023
- Investigator
- Dipesh K. Shah
- Observations
- 2
- Pages
- 5
- FEI number
- 3009864167
In short: On August 26, 2023, FDA issued a Form 483 with 2 observations to Gland Pharma Limited in Hyderabad, Telangana (FEI 3009864167) after an inspection that ran Aug 23 – Aug 26, 2023. The investigator was Dipesh K. Shah. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and records & documents account for 2 of 2 observations.
Most cited: 21 CFR 820.70(g) (1×) · 820.186 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The appropriate design, construction, placement, and installation of manufacturing equipment have not…
- 02
The quality system record has…
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 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 820.70(g)
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 & process controls and records & documents. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Gland Pharma Limited?
Dipesh K. Shah is named on this Form 483, for the inspection of Aug 23 – Aug 26, 2023. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Aug 23 – Aug 26, 2023, and the Form 483 is dated August 26, 2023.
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.