GORAN PHARMA PRIVATE LIMITED
FDA inspection history in Sihor, India, 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 Sihor, India.
Cited most
Across all GORAN PHARMA PRIVATE LIMITED observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.22(b)Responsibilities of quality control unit2
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.125(d)Labeling issuance1
The complete GORAN 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
Sihor, India
One close-out letter and one Form 483 · 2017 to 2018 · 17 observations
Latest: Close-out, Apr 24, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-04-24 | Close-out Close-out letter | Sihor, India | — | $99 |
| 2017-11-15 | 483 Form 483 | Sihor, India | 17 | $99 |
Investigators on these documents
FEI number 3009336980 · most recent document Apr 24, 2018
About GORAN PHARMA PRIVATE LIMITED
How many FDA Form 483s has GORAN PHARMA PRIVATE LIMITED received?
FDA Intel has 1 Form 483 on file for GORAN PHARMA PRIVATE LIMITED; the most recent is dated Nov 15, 2017.
When was GORAN PHARMA PRIVATE LIMITED last inspected by FDA?
The most recent FDA inspection document on file for GORAN PHARMA PRIVATE LIMITED is a Form 483 dated Nov 15, 2017, for the site in Sihor, India.
What did FDA cite at GORAN PHARMA PRIVATE LIMITED?
The regulations cited most in the observations on file for GORAN PHARMA PRIVATE LIMITED are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.166(a) (Stability testing), 2 times; 21 CFR 211.22(b) (Responsibilities of quality control unit), 2 times.