Lantech Pharmaceuticals Limited
FDA inspection history across 2 sites, 2019 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2019: one warning letter and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One warning letter and one Form 483, at Andhra Pradesh, India and Srikakulam, India.
- 2019The longest 483 on file: 9 observations over 12 pages at Srikakulam, India.
- 2023One Form 483, at Srikakulam, India.
Cited most
Across all Lantech Pharmaceuticals Limited observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.160General requirements1
The complete Lantech Pharmaceuticals Limited file.
All 3 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
Srikakulam, India
Two Form 483s · 2019 to 2023 · 12 observations
Latest: Form 483, Sep 12, 2023 →Andhra Pradesh, India
One warning letter · 2019
Latest: Warning letter, Aug 8, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-12 | 483 Form 483 | Srikakulam, India | 3 | $99 |
| 2019-08-08 | Warning letter Warning letter | Andhra Pradesh, India | — | $99 |
| 2019-03-15 | 483 Form 483 | Srikakulam, India | 9 | $99 |
Investigators on these documents
Dipesh K. Shah (1)Eric L. Dong (1)Guerlain Ulysse (1)Tenzin Jangchup (1)
FEI number 3012390454 · most recent document Sep 12, 2023
About Lantech Pharmaceuticals Limited
How many FDA Form 483s has Lantech Pharmaceuticals Limited received?
FDA Intel has 2 Form 483s on file for Lantech Pharmaceuticals Limited; the most recent is dated Sep 12, 2023.
When was Lantech Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Lantech Pharmaceuticals Limited is a Form 483 dated Sep 12, 2023, for the site in Srikakulam, India.
What did FDA cite at Lantech Pharmaceuticals Limited?
The regulations cited most in the observations on file for Lantech Pharmaceuticals Limited are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.
Has Lantech Pharmaceuticals Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lantech Pharmaceuticals Limited; the most recent is dated Aug 8, 2019.