Malladi Drugs & Pharmaceuticals Limited
FDA inspection history across 2 sites, 2017 to 2018
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2017: one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18One Form 483 and one close-out letter, at Ranipet, India and Chennai, India.
Cited most
Across all Malladi Drugs & Pharmaceuticals Limited observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.184Component, drug product container, closure, and labeling records1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.192Production record review1
The complete Malladi Drugs & Pharmaceuticals Limited file.
All 2 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
Chennai, India
One close-out letter · 2018
Latest: Close-out, Mar 9, 2018 →Ranipet, India
One Form 483 · 2017 · 8 observations
Latest: Form 483, Sep 8, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-03-09 | Close-out Close-out letter | Chennai, India | — | $99 |
| 2017-09-08 | 483 Form 483 | Ranipet, India | 8 | $99 |
Investigators on these documents
FEI number 3005115135 · most recent document Mar 9, 2018
About Malladi Drugs & Pharmaceuticals Limited
How many FDA Form 483s has Malladi Drugs & Pharmaceuticals Limited received?
FDA Intel has 1 Form 483 on file for Malladi Drugs & Pharmaceuticals Limited; the most recent is dated Sep 8, 2017.
When was Malladi Drugs & Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Malladi Drugs & Pharmaceuticals Limited is a Form 483 dated Sep 8, 2017, for the site in Ranipet, India.
What did FDA cite at Malladi Drugs & Pharmaceuticals Limited?
The regulations cited most in the observations on file for Malladi Drugs & Pharmaceuticals Limited are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.184 (Component, drug product container, closure, and labeling records), 1 time.