# FDA 483 - Happy Farm Botanicals - March 15, 2024

Source: https://www.globalkeysolutions.net/records/483/happy-farm-botanicals/a2a6e368-331e-4f7f-8469-2f4a5071741b

> FDA 483 for Happy Farm Botanicals on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Happy Farm Botanicals
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Happy Farm Botanicals, a contract manufacturer in Hyattsville, MD, received a Form 483 for significant deficiencies in their manufacturing processes. The inspection revealed a failure to establish adequate written procedures for production and process controls, including a lack of process validation for OTC drug products like sunscreen. Additionally, the firm's equipment cleaning and maintenance procedures were found to be deficient, lacking proper cleaning validation and detailed instructions.

## Related Officers

- [John D. McIntosh](https://www.globalkeysolutions.net/people/john-d-mcintosh/063cac5b-0933-4ecf-a9fb-835dd5d25ef2)
- [Johnny D. Nwankwo](https://www.globalkeysolutions.net/people/johnny-d-nwankwo/12d510d9-2ea8-44ae-807f-c8c05f63ce68)
- [company_representative](https://www.globalkeysolutions.net/people/nelson-n-ayangho/917cb8ea-904d-41a1-b522-2351d3cb1f74)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.globalkeysolutions.net/companies/happy-farm-botanicals/615bef80-6ef8-4c31-b16c-7749b2cd709a

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64