Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.
Form 483 issued September 8, 2023 · Bang Phli, Thailand
- Inspection
- Sep 4 – Sep 8, 2023
- Investigator
- Vivin George
- Observations
- 2
- Pages
- 2
- FEI number
- 3008264702
In short: On September 8, 2023, FDA issued a Form 483 with 2 observations to Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. in Bang Phli, Samut Prakan (FEI 3008264702) after an inspection that ran Sep 4 – Sep 8, 2023. The investigator was Vivin George. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.198(a) (1×) · 211.166(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
An adequate number of batches of each drug product are not tested nor are records of…
This inspection in context
Vivin George
20 documents · 2019–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmReckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.?
Vivin George is named on this Form 483, for the inspection of Sep 4 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. inspected by FDA?
The inspection ran Sep 4 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.?
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