Cosmetica Laboratories Inc.
Form 483 issued June 1, 2018 · Toronto, Canada
- Inspection
- May 28 – Jun 1, 2018
- Investigator
- Mindy M. Chou
- Observations
- 2
- Pages
- 3
- FEI number
- 3002759716
In short: On June 1, 2018, FDA issued a Form 483 with 2 observations to Cosmetica Laboratories Inc. in Toronto, Ontario (FEI 3002759716) after an inspection that ran May 28 – Jun 1, 2018. The investigator was Mindy M. Chou. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(a) (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmCosmetica Laboratories Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosmetica Laboratories Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Cosmetica Laboratories Inc.?
Mindy M. Chou is named on this Form 483, for the inspection of May 28 – Jun 1, 2018. Each investigator has a profile showing what they cite most.
When was Cosmetica Laboratories Inc. inspected by FDA?
The inspection ran May 28 – Jun 1, 2018, and the Form 483 is dated June 1, 2018.
How do I get the full Form 483 for Cosmetica 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.