Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.
FDA inspection history in Singapore, Singapore, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Singapore, Singapore.
Cited most
Across all Novartis Singapore Pharmaceutical Manufacturing Pte. observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
The complete Novartis Singapore Pharmaceutical Manufacturing Pte. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Singapore, Singapore
One Form 483 · 2020 · 5 observations
Latest: Form 483, Feb 15, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-15 | 483 Form 483 | Singapore, Singapore | 5 | $99 |
Investigators on these documents
Sarah Johnson (1)Thuy T. Nguyen (1)William Hallett (1)Yun Wu (1)
FEI number 3012958979 · most recent document Feb 15, 2020
About Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.
How many FDA Form 483s has Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. received?
FDA Intel has 1 Form 483 on file for Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.; the most recent is dated Feb 15, 2020.
When was Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. is a Form 483 dated Feb 15, 2020, for the site in Singapore, Singapore.
What did FDA cite at Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.?
The regulations cited most in the observations on file for Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.