GPT Pharmaceuticals Private Limited
FDA inspection history in Hyderabad, India, 2019 to 2023
- 2
- Close-outs
- 2
- Form 483s
Every document, by year
- Close-out
- Form 483
2019: one close-out letter and one Form 483; 2023: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One close-out letter and one Form 483, at Hyderabad, India.
- 2019The longest 483 on file: 10 observations over 16 pages at Hyderabad, India.
- 2023One close-out letter and one Form 483, at Hyderabad, India.
Cited most
Across all GPT Pharmaceuticals Private Limited observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.137Expiration dating1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
The complete GPT Pharmaceuticals Private Limited file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Hyderabad, India
Two close-out letters and two Form 483s · 2019 to 2023 · 12 observations
Latest: Close-out, Jun 2, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-02 | Close-out Close-out letter | Hyderabad, India | — | $99 |
| 2023-01-27 | 483 Form 483 | Hyderabad, India | 2 | $99 |
| 2019-12-17 | Close-out Close-out letter | Hyderabad, India | — | $99 |
| 2019-06-28 | 483 Form 483 | Hyderabad, India | 10 | $99 |
Investigators on these documents
Aeverse Lz Iming Zhang (1)Liming Zhang (1)Necige Lz Liming Zhang (1)
FEI number 3008311641 · most recent document Jun 2, 2023
About GPT Pharmaceuticals Private Limited
How many FDA Form 483s has GPT Pharmaceuticals Private Limited received?
FDA Intel has 2 Form 483s on file for GPT Pharmaceuticals Private Limited; the most recent is dated Jan 27, 2023.
When was GPT Pharmaceuticals Private Limited last inspected by FDA?
The most recent FDA inspection document on file for GPT Pharmaceuticals Private Limited is a Form 483 dated Jan 27, 2023, for the site in Hyderabad, India.
What did FDA cite at GPT Pharmaceuticals Private Limited?
The regulations cited most in the observations on file for GPT Pharmaceuticals Private Limited are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.137 (Expiration dating), 1 time.