MSD International GmbH (Singapore Branch)
Form 483 issued June 8, 2018 · Singapore, Singapore
- Inspection
- Jun 4 – Jun 8, 2018
- Investigator
- Jose E. Melendez
- Observations
- 1
- Pages
- 2
- FEI number
- 3003431146
In short: On June 8, 2018, FDA issued a Form 483 with 1 observation to MSD International GmbH (Singapore Branch) in Singapore, Singapore (FEI 3003431146) after an inspection that ran Jun 4 – Jun 8, 2018. The investigator was Jose E. Melendez. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMSD International GmbH (Singapore Branch) 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 MSD International GmbH (Singapore Branch)?
FDA listed 1 observation on this Form 483, mostly about production. 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 MSD International GmbH (Singapore Branch)?
Jose E. Melendez is named on this Form 483, for the inspection of Jun 4 – Jun 8, 2018. Each investigator has a profile showing what they cite most.
When was MSD International GmbH (Singapore Branch) inspected by FDA?
The inspection ran Jun 4 – Jun 8, 2018, and the Form 483 is dated June 8, 2018.
How do I get the full Form 483 for MSD International GmbH (Singapore Branch)?
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.