Coating Place Inc.
Form 483 issued March 4, 2019 · Verona, Wisconsin
- Inspection
- Mar 4, 2019
- Observations
- 1
- Pages
- 3
- FEI number
- 2126906
In short: On March 4, 2019, FDA issued a Form 483 with 1 observation to Coating Place Inc. in Verona, Wisconsin (FEI 2126906) after an inspection that ran Mar 4, 2019. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.453 (what are the requirements under this subpart for M written procedures?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.453 (1×)
What FDA observed
Preview: the opening words of each observation- 01
You did not follow written procedures for…
This inspection in context
Questions about this 483
What did FDA find at Coating Place Inc.?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.453 (what are the requirements under this subpart for M written procedures?). The opening words of each observation are shown on this page.
When was Coating Place Inc. inspected by FDA?
The inspection ran Mar 4, 2019, and the Form 483 is dated March 4, 2019.
How do I get the full Form 483 for Coating Place Inc.?
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.