Integrated Health Concepts Inc.
Form 483 issued July 23, 2021 · San Luis Obispo, California
- Inspection
- Jul 12 – Jul 23, 2021
- Investigators
- Gunneet Kaur· Jolanna A. Norton
- Observations
- 2
- Pages
- 3
- FEI number
- 3015131327
In short: On July 23, 2021, FDA issued a Form 483 with 2 observations to Integrated Health Concepts Inc. in San Luis Obispo, California (FEI 3015131327) after an inspection that ran Jul 12 – Jul 23, 2021. The investigators were Gunneet Kaur and Jolanna A. Norton.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Personnel touched equipment or other sm faces located outside of the ISO 5 classified aseptic processing…
- 02FDCA 501(a)(2)(A)
Personnel in an area that blocked the movement of first pass air around an open unit…
This inspection in context
Gunneet Kaur
9 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmIntegrated Health Concepts Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Integrated Health Concepts Inc.?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Integrated Health Concepts Inc.?
Gunneet Kaur and Jolanna A. Norton are named on this Form 483, for the inspection of Jul 12 – Jul 23, 2021. Each investigator has a profile showing what they cite most.
When was Integrated Health Concepts Inc. inspected by FDA?
The inspection ran Jul 12 – Jul 23, 2021, and the Form 483 is dated July 23, 2021.
How do I get the full Form 483 for Integrated Health Concepts 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.