Center For Ocular Prosthetics, LLC
Form 483 issued March 7, 2022 · Portland, Oregon
- Inspection
- Mar 4 – Mar 7, 2022
- Investigator
- Christopher S. Genther
- Observations
- 7
- Pages
- 5
- FEI number
- 1000524564
In short: On March 7, 2022, FDA issued a Form 483 with 7 observations to Center For Ocular Prosthetics, LLC in Portland, Oregon (FEI 1000524564) after an inspection that ran Mar 4 – Mar 7, 2022. The investigator was Christopher S. Genther. Most observations concern cAPA and records & documents.
At a glance
CAPA and records & documents account for 6 of 7 observations.
Most cited: 21 CFR 803 (2×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.198(a)21 CFR 803
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for corrective and preventive action…
- 0321 CFR 803.1721 CFR 803
Written MDR procedures have…
- 04
Procedures for device history records…
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 firmCenter For Ocular Prosthetics, 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 Center For Ocular Prosthetics, LLC?
FDA listed 7 observations on this Form 483, mostly about cAPA, records & documents and production & process controls. The opening words of each observation are shown on this page.
Who inspected Center For Ocular Prosthetics, LLC?
Christopher S. Genther is named on this Form 483, for the inspection of Mar 4 – Mar 7, 2022. Each investigator has a profile showing what they cite most.
When was Center For Ocular Prosthetics, LLC inspected by FDA?
The inspection ran Mar 4 – Mar 7, 2022, and the Form 483 is dated March 7, 2022.
How do I get the full Form 483 for Center For Ocular Prosthetics, 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.