# FDA 483 - Homeocare Laboratories, Inc. - June 04, 2021

Source: https://www.keypedia.com/records/483/homeocare-laboratories-inc/d854e64b-6e8d-46a5-b4c2-f793546b57db

> FDA 483 for Homeocare Laboratories, Inc. on June 04, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Homeocare Laboratories, Inc.
- Inspection Date: 2021-06-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Homeocare Laboratories, Inc. received a Form 483 citing significant deficiencies across its manufacturing operations for homeopathic drug products. Key issues include a lack of validated manufacturing processes, inadequate stability assessments, unvalidated cleaning and analytical methods, and failures in quality control procedures leading to premature product release. The inspection also identified deficiencies in equipment maintenance, ongoing GMP training, and material storage and segregation.

## Related Documents

- [WARNING_LETTER - 2017-01-11](https://www.keypedia.com/records/warning_letter/homeocare-laboratories-inc/703b4ace-cfdc-4784-b2ce-d347bd551b4e)
- [483 - 2019-12-13](https://www.keypedia.com/records/483/homeocare-laboratories-inc/3f98eaf0-7b20-4594-af74-6c07b8127a58)
- [WARNING_LETTER - 2019-12-13](https://www.keypedia.com/records/warning_letter/homeocare-laboratories-inc/74b15a31-82ec-4307-a28b-94585430cd24)
- [483 - 2023-02-21](https://www.keypedia.com/records/483/homeocare-laboratories-inc/4f167880-a89b-4afe-872c-86e16a7c54d9)
- [483 - 2024-03-20](https://www.keypedia.com/records/483/homeocare-laboratories-inc/8e6edd29-992c-445d-9f4a-c0fd8e5c784e)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [Tanya R. Syffrard](https://www.keypedia.com/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)

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