Zenara Pharma Private Limited
FDA inspection history in Hyderabad, India, 2019 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Hyderabad, India.
- 2019The longest 483 on file: 9 observations over 10 pages at Hyderabad, India.
- 2023One Form 483, at Hyderabad, India.
Cited most
Across all Zenara Pharma Private Limited observations on file
- 21 CFR 211.186Master production and control records2
- 21 CFR 211.192Production record review2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Zenara Pharma Private 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
Hyderabad, India
Two Form 483s · 2019 to 2023 · 10 observations
Latest: Form 483, Jan 20, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-20 | 483 Form 483 | Hyderabad, India | 1 | $99 |
| 2019-12-20 | 483 Form 483 | Hyderabad, India | 9 | $99 |
Investigators on these documents
FEI number 3005485158 · most recent document Jan 20, 2023
About Zenara Pharma Private Limited
How many FDA Form 483s has Zenara Pharma Private Limited received?
FDA Intel has 2 Form 483s on file for Zenara Pharma Private Limited; the most recent is dated Jan 20, 2023.
When was Zenara Pharma Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Zenara Pharma Private Limited is a Form 483 dated Jan 20, 2023, for the site in Hyderabad, India.
What did FDA cite at Zenara Pharma Private Limited?
The regulations cited most in the observations on file for Zenara Pharma Private Limited are 21 CFR 211.186 (Master production and control records), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.