MSD International GmbH (Singapore Branch)
Form 483 issued March 8, 2019 · Singapore, Singapore
- Inspection
- Mar 4 – Mar 8, 2019
- Investigator
- Justin A. Boyd
- Observations
- 6
- Pages
- 5
- FEI number
- 3002808083
In short: On March 8, 2019, FDA issued a Form 483 with 6 observations to MSD International GmbH (Singapore Branch) in Singapore, Singapore (FEI 3002808083) after an inspection that ran Mar 4 – Mar 8, 2019. The investigator was Justin A. Boyd. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 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
Procedures for thoroughly reviewing data have not been established and followed. |. Review of chromatography data…
- 02
Failure to demonstrate the manufacturing process…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Quality related complaints are…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) 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 211.160
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 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected MSD International GmbH (Singapore Branch)?
Justin A. Boyd is named on this Form 483, for the inspection of Mar 4 – Mar 8, 2019. Each investigator has a profile showing what they cite most.
When was MSD International GmbH (Singapore Branch) inspected by FDA?
The inspection ran Mar 4 – Mar 8, 2019, and the Form 483 is dated March 8, 2019.
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.