Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.
Form 483 issued February 15, 2020 · Singapore, Singapore
- Inspection
- Feb 10 – Feb 15, 2020
- Investigators
- Sarah Johnson· Thuy T. Nguyen· William Hallett
- Observations
- 5
- Pages
- 2
- FEI number
- 3012958979
In short: On February 15, 2020, FDA issued a Form 483 with 5 observations to Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. in Singapore, Singapore (FEI 3012958979) after an inspection that ran Feb 10 – Feb 15, 2020. The investigators were Sarah Johnson, Thuy T. Nguyen, William Hallett and Yun Wu. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
Most cited: 21 CFR 211.192 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate identification of root causes in your investigations for the deviations in the! system. The ineffective…
- 02
Transfer of analytical methods…
- 03
Inadequate Procedure for investigating…
- 04
Inadequate Procedure for management of…
This inspection in context
Sarah Johnson
4 documents · 2019–2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Singapore.
The firmNovartis Singapore Pharmaceutical Manufacturing Pte. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.?
Sarah Johnson, Thuy T. Nguyen, William Hallett and Yun Wu are named on this Form 483, for the inspection of Feb 10 – Feb 15, 2020. Each investigator has a profile showing what they cite most.
When was Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. inspected by FDA?
The inspection ran Feb 10 – Feb 15, 2020, and the Form 483 is dated February 15, 2020.
How do I get the full Form 483 for Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.