Lee Pharma Limited
FDA inspection history in Sangareddy, India, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Sangareddy, India.
Cited most
Across all Lee Pharma Limited observations on file
- 21 CFR 211.166Stability testing2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.87Retesting of approved components, drug product containers, and closures1
The complete Lee Pharma Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Sangareddy, India
One Form 483 · 2018 · 6 observations
Latest: Form 483, Nov 2, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-11-02 | 483 Form 483 | Sangareddy, India | 6 | $99 |
Investigators on these documents
FEI number 3009103626 · most recent document Nov 2, 2018
About Lee Pharma Limited
How many FDA Form 483s has Lee Pharma Limited received?
FDA Intel has 1 Form 483 on file for Lee Pharma Limited; the most recent is dated Nov 2, 2018.
When was Lee Pharma Limited last inspected by FDA?
The most recent FDA inspection document on file for Lee Pharma Limited is a Form 483 dated Nov 2, 2018, for the site in Sangareddy, India.
What did FDA cite at Lee Pharma Limited?
The regulations cited most in the observations on file for Lee Pharma Limited are 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.