The Feminina Group, Inc.
Form 483 issued March 14, 2018 · Seattle, Washington
- Inspection
- Mar 8 – Mar 14, 2018
- Investigators
- Christopher S. Genther· Stephen R. Souza
- Observations
- 3
- Pages
- 5
- FEI number
- 3003363230
In short: On March 14, 2018, FDA issued a Form 483 with 3 observations to The Feminina Group, Inc. in Seattle, Washington (FEI 3003363230) after an inspection that ran Mar 8 – Mar 14, 2018. The investigators were Christopher S. Genther and Stephen R. Souza. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.17 (1×) · 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Christopher S. Genther
4 documents · 2016–2022
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Washington.
The firmThe Feminina Group, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Feminina Group, Inc.?
FDA listed 3 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected The Feminina Group, Inc.?
Christopher S. Genther and Stephen R. Souza are named on this Form 483, for the inspection of Mar 8 – Mar 14, 2018. Each investigator has a profile showing what they cite most.
When was The Feminina Group, Inc. inspected by FDA?
The inspection ran Mar 8 – Mar 14, 2018, and the Form 483 is dated March 14, 2018.
How do I get the full Form 483 for The Feminina Group, Inc.?
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