Primrose Medical Inc
Form 483 issued October 26, 2022 · East Walpole, Massachusetts
- Inspection
- Oct 13 – Oct 26, 2022
- Investigator
- Sunita Pandey
- Observations
- 11
- Pages
- 8
- FEI number
- 1220905
In short: On October 26, 2022, FDA issued a Form 483 with 11 observations to Primrose Medical Inc in East Walpole, Massachusetts (FEI 1220905) after an inspection that ran Oct 13 – Oct 26, 2022. The investigator was Sunita Pandey. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by design controls.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.30(j)21 CFR 820
The design history file does not demonstrate that the design was de’veloped following the requirements…
- 02
Procedures for design control…
- 03
Risk analysis was not…
- 04
Procedmes for collective and preventive action have…
This inspection in context
Sunita Pandey
5 documents · 2022–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmPrimrose Medical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Primrose Medical Inc?
FDA listed 11 observations on this Form 483, mostly about design controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Primrose Medical Inc?
Sunita Pandey is named on this Form 483, for the inspection of Oct 13 – Oct 26, 2022. Each investigator has a profile showing what they cite most.
When was Primrose Medical Inc inspected by FDA?
The inspection ran Oct 13 – Oct 26, 2022, and the Form 483 is dated October 26, 2022.
How do I get the full Form 483 for Primrose Medical Inc?
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.