Hand Biomechanics Lab Inc
Form 483 issued July 5, 2017 · Sacramento, California
- Inspection
- Jun 22 – Jul 5, 2017
- Investigator
- Quynh Strandberg
- Observations
- 6
- Pages
- 4
- FEI number
- 2919128
In short: On July 5, 2017, FDA issued a Form 483 with 6 observations to Hand Biomechanics Lab Inc in Sacramento, California (FEI 2919128) after an inspection that ran Jun 22 – Jul 5, 2017. The investigator was Quynh Strandberg. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
CAPA and production & process controls account for 6 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
A validated process was not revalidated when changes…
This inspection in context
Quynh Strandberg
2 documents · 2009–2017
Cites 820.75(a) (process validation) more than any other section. Most of their documents are for sites in California.
The firmHand Biomechanics Lab Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hand Biomechanics Lab Inc?
FDA listed 6 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Hand Biomechanics Lab Inc?
Quynh Strandberg is named on this Form 483, for the inspection of Jun 22 – Jul 5, 2017. Each investigator has a profile showing what they cite most.
When was Hand Biomechanics Lab Inc inspected by FDA?
The inspection ran Jun 22 – Jul 5, 2017, and the Form 483 is dated July 5, 2017.
How do I get the full Form 483 for Hand Biomechanics Lab 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.