Dalton Chemical Laboratories Inc.
Form 483 issued December 9, 2022 · Toronto, Canada
- Inspection
- Dec 1 – Dec 9, 2022
- Investigator
- Taichun Qin
- Observations
- 6
- Pages
- 6
- FEI number
- 3003094018
In short: On December 9, 2022, FDA issued a Form 483 with 6 observations to Dalton Chemical Laboratories Inc. in Toronto, Ontario (FEI 3003094018) after an inspection that ran Dec 1 – Dec 9, 2022. The investigator was Taichun Qin. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Results of stability testing are not used…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmDalton Chemical Laboratories Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dalton Chemical Laboratories Inc.?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Dalton Chemical Laboratories Inc.?
Taichun Qin is named on this Form 483, for the inspection of Dec 1 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was Dalton Chemical Laboratories Inc. inspected by FDA?
The inspection ran Dec 1 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
How do I get the full Form 483 for Dalton Chemical Laboratories 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.