Synergy Health Outsourcing Solutions Inc
Form 483 issued July 6, 2016 · Maple Grove, Minnesota
- Inspection
- Jun 22 – Jul 6, 2016
- Investigator
- Marissa S. Steinhagen
- Observations
- 3
- Pages
- 3
- FEI number
- 3011024991
In short: On July 6, 2016, FDA issued a Form 483 with 3 observations to Synergy Health Outsourcing Solutions Inc in Maple Grove, Minnesota (FEI 3011024991) after an inspection that ran Jun 22 – Jul 6, 2016. The investigator was Marissa S. Steinhagen. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control environmental conditions have…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 03
Procedures for corrective and preventive action have…
This inspection in context
Marissa S. Steinhagen
3 documents · 2016–2019
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmSynergy Health Outsourcing Solutions Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Synergy Health Outsourcing Solutions Inc?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. 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 Synergy Health Outsourcing Solutions Inc?
Marissa S. Steinhagen is named on this Form 483, for the inspection of Jun 22 – Jul 6, 2016. Each investigator has a profile showing what they cite most.
When was Synergy Health Outsourcing Solutions Inc inspected by FDA?
The inspection ran Jun 22 – Jul 6, 2016, and the Form 483 is dated July 6, 2016.
How do I get the full Form 483 for Synergy Health Outsourcing Solutions 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.