Lac-Mac Limited
Form 483 issued November 12, 2015 · London, Canada
- Inspection
- Nov 9 – Nov 12, 2015
- Investigator
- That Q. Dang
- Observations
- 2
- Pages
- 3
In short: On November 12, 2015, FDA issued a Form 483 with 2 observations to Lac-Mac Limited in London, Ontario NY B after an inspection that ran Nov 9 – Nov 12, 2015. The investigator was That Q. Dang. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×) · 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for corrective and preventive action have…
This inspection in context
That Q. Dang
4 documents · 2015–2016
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Canada.
The firmLac-Mac Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lac-Mac Limited?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Lac-Mac Limited?
That Q. Dang is named on this Form 483, for the inspection of Nov 9 – Nov 12, 2015. Each investigator has a profile showing what they cite most.
When was Lac-Mac Limited inspected by FDA?
The inspection ran Nov 9 – Nov 12, 2015, and the Form 483 is dated November 12, 2015.
How do I get the full Form 483 for Lac-Mac Limited?
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.