Form 483 · FEI 3000296634
Form 483 issued December 8, 2022 · Ercuis, France
- Inspection
- Dec 5 – Dec 8, 2022
- Investigator
- Colin E. Tack
- Observations
- 4
- Pages
- 6
- FEI number
- 3000296634
In short: On December 8, 2022, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Ercuis, Oise (FEI 3000296634) after an inspection that ran Dec 5 – Dec 8, 2022. The investigator was Colin E. Tack.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 02
The design verification results, including identification of the design, method(s), the date and the individual(s) performing…
- 03
Requirements that must be met by contractors and consultants…
- 04
Procedures for corrective and preventive action…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Colin E. Tack is named on this Form 483, for the inspection of Dec 5 – Dec 8, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Dec 5 – Dec 8, 2022, and the Form 483 is dated December 8, 2022.
How do I get the full Form 483 for an FDA-inspected site?
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.