Roche Singapore Technical Operations Pte. Ltd.
FDA inspection history in Singapore, Singapore, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Singapore, Singapore.
Cited most
Across all Roche Singapore Technical Operations Pte. observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.52Washing and toilet facilities1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Roche Singapore Technical Operations Pte. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Singapore, Singapore
One Form 483 · 2022 · 6 observations
Latest: Form 483, Aug 1, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-08-01 | 483 Form 483 | Singapore, Singapore | 6 | $99 |
Investigators on these documents
FEI number 3007164129 · most recent document Aug 1, 2022
About Roche Singapore Technical Operations Pte. Ltd.
How many FDA Form 483s has Roche Singapore Technical Operations Pte. Ltd. received?
FDA Intel has 1 Form 483 on file for Roche Singapore Technical Operations Pte. Ltd.; the most recent is dated Aug 1, 2022.
When was Roche Singapore Technical Operations Pte. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Roche Singapore Technical Operations Pte. Ltd. is a Form 483 dated Aug 1, 2022, for the site in Singapore, Singapore.
What did FDA cite at Roche Singapore Technical Operations Pte. Ltd.?
The regulations cited most in the observations on file for Roche Singapore Technical Operations Pte. Ltd. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.