Apollo Health and Beauty Care
Form 483 issued August 16, 2019 · Toronto, Canada
- Inspection
- Aug 12 – Aug 16, 2019
- Observations
- 3
- Pages
- 5
- FEI number
- 3003173295
In short: On August 16, 2019, FDA issued a Form 483 with 3 observations to Apollo Health and Beauty Care in Toronto, Ontario (FEI 3003173295) after an inspection that ran Aug 12 – Aug 16, 2019. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Questions about this 483
What did FDA find at Apollo Health and Beauty Care?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
When was Apollo Health and Beauty Care inspected by FDA?
The inspection ran Aug 12 – Aug 16, 2019, and the Form 483 is dated August 16, 2019.
How do I get the full Form 483 for Apollo Health and Beauty Care?
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.