Gland Pharma Limited
Form 483 issued February 25, 2025 · Anakapalli District, India
- Inspection
- Feb 19 – Feb 25, 2025
- Observations
- 3
- Pages
- 4
- FEI number
- 3010142300
In short: On February 25, 2025, FDA issued a Form 483 with 3 observations to Gland Pharma Limited in Anakapalli District, Andhra Pradesh (FEI 3010142300) after an inspection that ran Feb 19 – Feb 25, 2025. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Questions about this 483
What did FDA find at Gland Pharma Limited?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Feb 19 – Feb 25, 2025, and the Form 483 is dated February 25, 2025.
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.