MSD International GmbH (Puerto Rico Branch) LLC
Form 483 issued February 26, 2020 · Las Piedras, Puerto Rico
- Inspection
- Feb 5 – Feb 26, 2020
- Investigator
- Marian E. Ramirez
- Observations
- 2
- Pages
- 6
- FEI number
- 2650155
In short: On February 26, 2020, FDA issued a Form 483 with 2 observations to MSD International GmbH (Puerto Rico Branch) LLC in Las Piedras, Puerto Rico (FEI 2650155) after an inspection that ran Feb 5 – Feb 26, 2020. The investigator was Marian E. Ramirez. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (1×) · 314.81(b)(1)(ii) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
An NDA-Field Alert Report was not submitted within three working days of receipt of information conceming…
This inspection in context
Marian E. Ramirez
20 documents · 2016–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmMSD International GmbH (Puerto Rico Branch) LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MSD International GmbH (Puerto Rico Branch) LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected MSD International GmbH (Puerto Rico Branch) LLC?
Marian E. Ramirez is named on this Form 483, for the inspection of Feb 5 – Feb 26, 2020. Each investigator has a profile showing what they cite most.
When was MSD International GmbH (Puerto Rico Branch) LLC inspected by FDA?
The inspection ran Feb 5 – Feb 26, 2020, and the Form 483 is dated February 26, 2020.
How do I get the full Form 483 for MSD International GmbH (Puerto Rico Branch) LLC?
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