Gland Pharma Limited
Form 483 issued July 14, 2023 · Hyderabad, India
- Inspection
- Jul 3 – Jul 14, 2023
- Investigators
- Alan P. Kurtzberg· Youkeun Kim
- Observations
- 1
- Pages
- 2
- FEI number
- 3002647489
In short: On July 14, 2023, FDA issued a Form 483 with 1 observation to Gland Pharma Limited in Hyderabad, Telangana (FEI 3002647489) after an inspection that ran Jul 3 – Jul 14, 2023. The investigators were Alan P. Kurtzberg and Youkeun Kim. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.194(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 laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Gland Pharma Limited?
Alan P. Kurtzberg and Youkeun Kim are named on this Form 483, for the inspection of Jul 3 – Jul 14, 2023. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Jul 3 – Jul 14, 2023, and the Form 483 is dated July 14, 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.