Gland Pharma Limited
Form 483 issued August 2, 2024 · Hyderabad, India
- Inspection
- Jul 25 – Aug 2, 2024
- Investigators
- Jeffrey P. Raimondi· Roger F. Zabinski
- Observations
- 3
- Pages
- 5
- FEI number
- 3009864167
In short: On August 2, 2024, FDA issued a Form 483 with 3 observations to Gland Pharma Limited in Hyderabad, Telangana (FEI 3009864167) after an inspection that ran Jul 25 – Aug 2, 2024. The investigators were Jeffrey P. Raimondi and Roger F. Zabinski. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gland Pharma Limited?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Gland Pharma Limited?
Jeffrey P. Raimondi and Roger F. Zabinski are named on this Form 483, for the inspection of Jul 25 – Aug 2, 2024. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Jul 25 – Aug 2, 2024, and the Form 483 is dated August 2, 2024.
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.