MSD International GmbH (Singapore Branch)
Form 483 issued September 3, 2021 · Singapore, Singapore
- Inspection
- Aug 25 – Sep 3, 2021
- Investigators
- Wendy G. Tan· Zhihao Peter Qiu
- Observations
- 5
- Pages
- 3
- FEI number
- 3004611169
In short: On September 3, 2021, FDA issued a Form 483 with 5 observations to MSD International GmbH (Singapore Branch) in Singapore, Singapore (FEI 3004611169) after an inspection that ran Aug 25 – Sep 3, 2021. The investigators were Wendy G. Tan and Zhihao Peter Qiu. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish and follow appropriate written procedures that…
- 02
There is no assurance that the manufacturing process at the MSD Singapore Biotech facility is capable…
- 03
Your written procedures for manufacturing process are inadequate to assure that the drug products have the…
- 04
Establishment of the reliability of the container and closure supplier's Certificate of Analysis is deficient in…
This inspection in context
Wendy G. Tan
11 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Singapore.
The firmMSD International GmbH (Singapore Branch) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
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 5 observations on this Form 483, mostly about production, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected MSD International GmbH (Singapore Branch)?
Wendy G. Tan and Zhihao Peter Qiu are named on this Form 483, for the inspection of Aug 25 – Sep 3, 2021. Each investigator has a profile showing what they cite most.
When was MSD International GmbH (Singapore Branch) inspected by FDA?
The inspection ran Aug 25 – Sep 3, 2021, and the Form 483 is dated September 3, 2021.
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.