Gland Pharma Limited
Form 483 issued July 25, 2024 · Hyderabad, India
- Inspection
- Jul 22 – Jul 25, 2024
- Investigators
- Jeffrey P. Raimondi· Roger F. Zabinski
- Observations
- 2
- Pages
- 2
- FEI number
- 3002647489
In short: On July 25, 2024, FDA issued a Form 483 with 2 observations to Gland Pharma Limited in Hyderabad, Telangana (FEI 3002647489) after an inspection that ran Jul 22 – Jul 25, 2024. The investigators were Jeffrey P. Raimondi and Roger F. Zabinski. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×) · 211.180(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Observation 2: scanned text, readable in the full document.
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 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
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 211.22 (responsibilities of quality control unit). 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 22 – Jul 25, 2024. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Jul 22 – Jul 25, 2024, and the Form 483 is dated July 25, 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.