# FDA 483 - Homeocare Laboratories, Inc. - December 13, 2019

Source: https://www.keypedia.com/records/483/homeocare-laboratories-inc/3f98eaf0-7b20-4594-af74-6c07b8127a58

> FDA 483 for Homeocare Laboratories, Inc. on December 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Homeocare Laboratories, Inc.
- Inspection Date: 2019-12-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Homeocare Laboratories, Inc. in Yonkers, NY, a homeopathic drug manufacturer, revealed significant deficiencies across its operations. The firm lacked adequate written procedures for production and process controls, failed to perform essential product testing and stability assessments, and did not properly validate manufacturing processes or equipment cleaning. Additionally, expired ingredients were used, and raw materials were accepted from unqualified vendors without proper identity testing.

## Related Documents

- [WARNING_LETTER - 2017-01-11](https://www.keypedia.com/records/warning_letter/homeocare-laboratories-inc/703b4ace-cfdc-4784-b2ce-d347bd551b4e)
- [WARNING_LETTER - 2019-12-13](https://www.keypedia.com/records/warning_letter/homeocare-laboratories-inc/74b15a31-82ec-4307-a28b-94585430cd24)
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## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/homeocare-laboratories-inc/c4464988-ca0b-4146-b817-3dfb461a073e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961