Molecular MS Diagnostics, LLC
Form 483 issued April 16, 2024 · Warwick, Rhode Island
- Inspection
- Apr 8 – Apr 16, 2024
- Investigator
- Erik W. Koester
- Observations
- 2
- Pages
- 4
- FEI number
- 3011589219
In short: On April 16, 2024, FDA issued a Form 483 with 2 observations to Molecular MS Diagnostics, LLC in Warwick, Rhode Island (FEI 3011589219) after an inspection that ran Apr 8 – Apr 16, 2024. The investigator was Erik W. Koester. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×) · 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMolecular MS Diagnostics, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Molecular MS Diagnostics, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Molecular MS Diagnostics, LLC?
Erik W. Koester is named on this Form 483, for the inspection of Apr 8 – Apr 16, 2024. Each investigator has a profile showing what they cite most.
When was Molecular MS Diagnostics, LLC inspected by FDA?
The inspection ran Apr 8 – Apr 16, 2024, and the Form 483 is dated April 16, 2024.
How do I get the full Form 483 for Molecular MS Diagnostics, LLC?
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.