Medicap Laboratories
Form 483 issued June 14, 2019 · Toronto, Canada
- Observations
- 5
- Pages
- 4
- FEI number
- 3006370451
In short: On June 14, 2019, FDA issued a Form 483 with 5 observations to Medicap Laboratories in Toronto, Ontario (FEI 3006370451). Most observations concern facilities & equipment and quality system.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Written control and testing procedures…
This inspection in context
Questions about this 483
What did FDA find at Medicap Laboratories?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
When was Medicap Laboratories inspected by FDA?
This Form 483 is dated June 14, 2019.
How do I get the full Form 483 for Medicap Laboratories?
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.