Roche Singapore Technical Operations Pte. Ltd.
Form 483 issued August 1, 2022 · Singapore, Singapore
- Inspection
- Jul 25 – Aug 1, 2022
- Investigators
- Michael A. Moses· Riley Myers· Wendy G. Tan
- Observations
- 6
- Pages
- 4
- FEI number
- 3007164129
In short: On August 1, 2022, FDA issued a Form 483 with 6 observations to Roche Singapore Technical Operations Pte. Ltd. in Singapore, Singapore (FEI 3007164129) after an inspection that ran Jul 25 – Aug 1, 2022. The investigators were Michael A. Moses, Riley Myers and Wendy G. Tan. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Microbial and cross-contamination control procedures are inadequate to ensure that shared product-contact manufacturing…
- 02
Your firm failed to follow appropriate written procedures that are designed to ensure tha O@ drug…
- 03
Diserepancy/Unplanned Event root cause investigations are inadequate, leading…
- 04
Production and control procedures…
This inspection in context
Michael A. Moses
1 document · 2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Singapore.
The firmRoche Singapore Technical Operations Pte. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Roche Singapore Technical Operations Pte. Ltd.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Roche Singapore Technical Operations Pte. Ltd.?
Michael A. Moses, Riley Myers and Wendy G. Tan are named on this Form 483, for the inspection of Jul 25 – Aug 1, 2022. Each investigator has a profile showing what they cite most.
When was Roche Singapore Technical Operations Pte. Ltd. inspected by FDA?
The inspection ran Jul 25 – Aug 1, 2022, and the Form 483 is dated August 1, 2022.
How do I get the full Form 483 for Roche Singapore Technical Operations 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.