GPT Pharmaceuticals Private Limited
Form 483 issued January 27, 2023 · Hyderabad, India
- Inspection
- Jan 19 – Jan 27, 2023
- Observations
- 2
- Pages
- 2
- FEI number
- 3008311641
In short: On January 27, 2023, FDA issued a Form 483 with 2 observations to GPT Pharmaceuticals Private Limited in Hyderabad, Telangana (FEI 3008311641) after an inspection that ran Jan 19 – Jan 27, 2023. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Questions about this 483
What did FDA find at GPT Pharmaceuticals Private Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was GPT Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Jan 19 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for GPT Pharmaceuticals Private 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.