Gland Pharma Limited
Form 483 issued November 7, 2019 · Hyderabad, India
- Inspection
- Oct 31 – Nov 7, 2019
- Investigator
- Michael A. Charles
- Observations
- 4
- Pages
- 4
- FEI number
- 3009864167
In short: On November 7, 2019, FDA issued a Form 483 with 4 observations to Gland Pharma Limited in Hyderabad, Telangana (FEI 3009864167) after an inspection that ran Oct 31 – Nov 7, 2019. The investigator was Michael A. Charles. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 04
Representative samples are not taken of each shipment of each lot of components for…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gland Pharma Limited?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Gland Pharma Limited?
Michael A. Charles is named on this Form 483, for the inspection of Oct 31 – Nov 7, 2019. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Oct 31 – Nov 7, 2019, and the Form 483 is dated November 7, 2019.
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.