GPT Pharmaceuticals Private Limited
Form 483 issued June 28, 2019 · Hyderabad, India
- Investigators
- Aeverse Lz Iming Zhang· Liming Zhang· Necige Lz Liming Zhang
- Observations
- 10
- Pages
- 16
- FEI number
- 3008311641
In short: On June 28, 2019, FDA issued a Form 483 with 10 observations to GPT Pharmaceuticals Private Limited in Hyderabad, Telangana (FEI 3008311641). The investigators were Aeverse Lz Iming Zhang, Liming Zhang and Necige Lz Liming Zhang. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Employees are not given training in the particular operations they perform as…
This inspection in context
Aeverse Lz Iming Zhang
1 document · 2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmGPT Pharmaceuticals Private Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GPT Pharmaceuticals Private Limited?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and packaging & labeling. 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 GPT Pharmaceuticals Private Limited?
Aeverse Lz Iming Zhang, Liming Zhang and Necige Lz Liming Zhang are named on this Form 483. Each investigator has a profile showing what they cite most.
When was GPT Pharmaceuticals Private Limited inspected by FDA?
This Form 483 is dated June 28, 2019.
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.