Greer Laboratories, Inc.
Form 483 issued November 1, 2022 · Lenoir, North Carolina
- Inspection
- Oct 25 – Nov 1, 2022
- Observations
- 7
- Pages
- 5
- FEI number
- 1011574
In short: On November 1, 2022, FDA issued a Form 483 with 7 observations to Greer Laboratories, Inc. in Lenoir, North Carolina (FEI 1011574) after an inspection that ran Oct 25 – Nov 1, 2022. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and management controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The design was not validated under defined operating conditions and using initial production units, lots or…
- 02
A report of the required information regarding device correction and removal actions was not sent to…
- 03
Corrective and preventive action activities and/or results have not been adequately…
- 04
Procedures for corrective and preventive action…
This inspection in context
Questions about this 483
What did FDA find at Greer Laboratories, Inc.?
FDA listed 7 observations on this Form 483, mostly about cAPA, management controls and design controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
When was Greer Laboratories, Inc. inspected by FDA?
The inspection ran Oct 25 – Nov 1, 2022, and the Form 483 is dated November 1, 2022.
How do I get the full Form 483 for Greer Laboratories, Inc.?
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