Vortech Pharmaceuticals, Ltd.
Form 483 issued February 9, 2022 · Dearborn, Michigan
- Observations
- 4
- Pages
- 2
- FEI number
- 1810390
In short: On February 9, 2022, FDA issued a Form 483 with 4 observations to Vortech Pharmaceuticals, Ltd. in Dearborn, Michigan (FEI 1810390). Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Written procedures are not established for evaluations done at least annually and including provisions for a…
- 03
Each batch of drugproduct required to be free of objectionable microorganisms is not tested through appropriate…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
This inspection in context
Questions about this 483
What did FDA find at Vortech Pharmaceuticals, Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
When was Vortech Pharmaceuticals, Ltd. inspected by FDA?
This Form 483 is dated February 9, 2022.
How do I get the full Form 483 for Vortech Pharmaceuticals, Ltd.?
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.