Novocol Pharmaceutical of Canada, Inc.
Form 483 issued June 18, 2019 · Cambridge, Canada
- Inspection
- Jun 10 – Jun 18, 2019
- Investigator
- Bei Y. He
- Observations
- 1
- Pages
- 2
- FEI number
- 3002807757
In short: On June 18, 2019, FDA issued a Form 483 with 1 observation to Novocol Pharmaceutical of Canada, Inc. in Cambridge, Ontario (FEI 3002807757) after an inspection that ran Jun 10 – Jun 18, 2019. The investigator was Bei Y. He. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
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 firmNovocol Pharmaceutical of Canada, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novocol Pharmaceutical of Canada, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Novocol Pharmaceutical of Canada, Inc.?
Bei Y. He is named on this Form 483, for the inspection of Jun 10 – Jun 18, 2019. Each investigator has a profile showing what they cite most.
When was Novocol Pharmaceutical of Canada, Inc. inspected by FDA?
The inspection ran Jun 10 – Jun 18, 2019, and the Form 483 is dated June 18, 2019.
How do I get the full Form 483 for Novocol Pharmaceutical of Canada, 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.