Innocore Sales & Marketing Inc
Form 483 issued June 6, 2019 · Woodstock, Canada
- Inspection
- Jun 3 – Jun 6, 2019
- Investigator
- Bei Y. He
- Observations
- 12
- Pages
- 7
- FEI number
- 3010034070
In short: On June 6, 2019, FDA issued a Form 483 with 12 observations to Innocore Sales & Marketing Inc in Woodstock, ONTARIO (FEI 3010034070) after an inspection that ran Jun 3 – Jun 6, 2019. The investigator was Bei Y. He. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with…
- 03
Your master production and control records for each drug product were not prepared, dated, and signed…
- 04
Admunclrent 1 ditt EMPLOYEE(S) S]ONATURE OATEISSUED Manufacturer There are no written procedures for production and process…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmInnocore Sales & Marketing Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innocore Sales & Marketing Inc?
FDA listed 12 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Innocore Sales & Marketing Inc?
Bei Y. He is named on this Form 483, for the inspection of Jun 3 – Jun 6, 2019. Each investigator has a profile showing what they cite most.
When was Innocore Sales & Marketing Inc inspected by FDA?
The inspection ran Jun 3 – Jun 6, 2019, and the Form 483 is dated June 6, 2019.
How do I get the full Form 483 for Innocore Sales & Marketing 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.