SRC Medical, Inc
Form 483 issued August 3, 2016 · Hanover, Massachusetts
- Inspection
- Jul 19 – Aug 3, 2016
- Investigators
- Justine M. Corson· Sean R. Marcsisin
- Observations
- 1
- Pages
- 5
- FEI number
- 1218347
In short: On August 3, 2016, FDA issued a Form 483 with 1 observation to SRC Medical, Inc in Hanover, Massachusetts (FEI 1218347) after an inspection that ran Jul 19 – Aug 3, 2016. The investigators were Justine M. Corson and Sean R. Marcsisin. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Requirements have not been adequately established to address personnel cleanliness…
This inspection in context
Justine M. Corson
5 documents · 2012–2019
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSRC Medical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SRC Medical, Inc?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected SRC Medical, Inc?
Justine M. Corson and Sean R. Marcsisin are named on this Form 483, for the inspection of Jul 19 – Aug 3, 2016. Each investigator has a profile showing what they cite most.
When was SRC Medical, Inc inspected by FDA?
The inspection ran Jul 19 – Aug 3, 2016, and the Form 483 is dated August 3, 2016.
How do I get the full Form 483 for SRC 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.