Affinity Medical Technologies LLC
Form 483 issued March 3, 2015 · Costa Mega, California
- Inspection
- Feb 24 – Mar 3, 2015
- Investigator
- Angela Shepas
- Observations
- 1
- Pages
- 2
- FEI number
- 3001236763
In short: On March 3, 2015, FDA issued a Form 483 with 1 observation to Affinity Medical Technologies LLC in Costa Mega, California (FEI 3001236763) after an inspection that ran Feb 24 – Mar 3, 2015. The investigator was Angela Shepas. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Angela Shepas
1 document · 2015
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in California.
The firmAffinity Medical Technologies LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Affinity Medical Technologies LLC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Affinity Medical Technologies LLC?
Angela Shepas is named on this Form 483, for the inspection of Feb 24 – Mar 3, 2015. Each investigator has a profile showing what they cite most.
When was Affinity Medical Technologies LLC inspected by FDA?
The inspection ran Feb 24 – Mar 3, 2015, and the Form 483 is dated March 3, 2015.
How do I get the full Form 483 for Affinity Medical Technologies LLC?
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.