# FDA 483 - Apollo Health And Beauty Care, Inc. - April 03, 2020

Source: https://www.keypedia.com/records/483/apollo-health-and-beauty-care-inc/e925647f-3911-4192-8a29-cd63c84d1a98

> FDA 483 for Apollo Health And Beauty Care, Inc. on April 03, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apollo Health And Beauty Care, Inc.
- Inspection Date: 2020-04-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Apollo Health And Beauty Care, Inc. in Toronto, Canada, received a Form 483 following an inspection from March 30 to April 3, 2020. The inspection revealed significant deficiencies in laboratory controls, quality system procedures, and investigation processes. Key issues included inadequate product release testing, poor documentation of lab controls, failure to investigate discrepancies, and a quality unit that did not fully follow or enforce written procedures, including those for OOS results, data review, and stability testing.

## Related Documents

- [483 - 2019-08-16](https://www.keypedia.com/records/483/apollo-health-and-beauty-care-inc/4caefc22-3024-47e1-8a27-acd039c7ea7a)
- [WARNING_LETTER - 2019-08-16](https://www.keypedia.com/records/warning_letter/apollo-health-and-beauty-care-inc/1bb6a0d2-5e1f-42a4-a3be-0fd6580c2df6)
- [483 - 2022-04-15](https://www.keypedia.com/records/483/apollo-health-and-beauty-care-inc/63747db0-c01a-4cf0-8333-1d4d5615cb3c)

## Related Officers

- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)
- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/apollo-health-and-beauty-care-inc/6de620ec-319a-4f2e-a45d-40e6f4e356bf

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1