Haemonetics Software Solutions
Form 483 issued March 21, 2017 · El Dorado Hills, California
- Inspection
- Mar 3 – Mar 21, 2017
- Investigator
- Seema S. Singh
- Observations
- 1
- Pages
- 1
- FEI number
- 1000221345
In short: On March 21, 2017, FDA issued a Form 483 with 1 observation to Haemonetics Software Solutions in El Dorado Hills, California (FEI 1000221345) after an inspection that ran Mar 3 – Mar 21, 2017. The investigator was Seema S. Singh. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design input have…
This inspection in context
Seema S. Singh
6 documents · 2015–2020
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmHaemonetics Software Solutions history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Haemonetics Software Solutions?
FDA listed 1 observation on this Form 483, mostly about design 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 Haemonetics Software Solutions?
Seema S. Singh is named on this Form 483, for the inspection of Mar 3 – Mar 21, 2017. Each investigator has a profile showing what they cite most.
When was Haemonetics Software Solutions inspected by FDA?
The inspection ran Mar 3 – Mar 21, 2017, and the Form 483 is dated March 21, 2017.
How do I get the full Form 483 for Haemonetics Software Solutions?
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