Apollo Health and Beauty Care
Form 483 issued April 3, 2020 · Toronto, Canada
- Inspection
- Mar 30 – Apr 3, 2020
- Investigator
- Kham Phommachanh
- Observations
- 5
- Pages
- 7
- FEI number
- 3003173295
In short: On April 3, 2020, FDA issued a Form 483 with 5 observations to Apollo Health and Beauty Care in Toronto, Ontario (FEI 3003173295) after an inspection that ran Mar 30 – Apr 3, 2020. The investigator was Kham Phommachanh. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Established laboratory control mechanisms are not documented at…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
The firmApollo Health and Beauty Care history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apollo Health and Beauty Care?
FDA listed 5 observations on this Form 483, mostly about quality system and laboratory controls. 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 Apollo Health and Beauty Care?
Kham Phommachanh is named on this Form 483, for the inspection of Mar 30 – Apr 3, 2020. Each investigator has a profile showing what they cite most.
When was Apollo Health and Beauty Care inspected by FDA?
The inspection ran Mar 30 – Apr 3, 2020, and the Form 483 is dated April 3, 2020.
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.