# FDA 483 - Brands International Corporation - June 21, 2024

Source: https://www.keypedia.com/records/483/brands-international-corporation/9763c0a5-85b7-4e38-9daf-b9365f396b58

> FDA 483 for Brands International Corporation on June 21, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brands International Corporation
- Inspection Date: 2024-06-21
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: **FDA 483 Summary: Brands International Corporation**

**Inspection Details:**
- **Company:** Brands International Corporation
- **Location:** 594 Newmarket Blvd, Newmarket, L3X 2S2, Canada
- **Inspection Dates:** June 17-21, 2024
- **Inspector"s Report Recipient:** Ms. Reva A. Kohn, Chief Financial Officer
- **Establishment Type:** Over-the-Counter (OTC) Drug Manufacturer

**Main Violations/Issues:**
1. **Quality Control Deficiencies:** The quality control unit lacks authority and responsibility to approve or reject components and drug products. There were failures in ensuring product safety, identity, strength, and quality, with discrepancies inadequately investigated and misleading information provided.
   
2. **Inadequate Investigations:** Investigations into product discrepancies were insufficient. For example, a customer complaint about mold in lotion batches was not properly documented or extended to other potentially affected batches.

3. **Lack of Laboratory Testing:** Products were released without appropriate laboratory testing to confirm conformance to specifications, including the identity and strength of active ingredients.

4. **Incomplete Batch Records:** Batch production records lacked complete information necessary for ensuring compliance with established specifications.

**Regulatory Framework:**
The inspection highlighted non-compliance with Current Good Manufacturing Practices (CGMP), which are essential for ensuring the quality and safety of drug products.

**Required Actions:**
- **Enhance Quality Control:** Establish a robust quality control unit with clear authority and responsibility for product approval and rejection.
- **Improve Investigation Processes:** Develop comprehensive investigation procedures for product discrepancies and ensure thorough documentation and traceability.
- **Implement Laboratory Testing:** Conduct and document appropriate laboratory tests for all batches before release.
- **Maintain Complete Records:** Ensure batch production records are complete and accurately reflect all aspects of production and quality control.

Brands International Corporation must address these issues promptly to comply with FDA regulations and ensure the safety and efficacy of its OTC drug products.

## Related Documents

- [483 - 2023-10-27](https://www.keypedia.com/records/483/brands-international-corporation/7039fc14-89df-47e7-b121-8cad441703d7)
- [483 - 2024-06-21](https://www.keypedia.com/records/483/brands-international-corporation/47700534-0a32-48a9-8b59-8dcf581156ab)
- [WARNING_LETTER - 2024-06-21](https://www.keypedia.com/records/warning_letter/brands-international-corporation/e8e6f46f-d31e-4dc5-b9b3-4037c252d340)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

Company: https://www.keypedia.com/companies/brands-international-corporation/5e7e54da-9fbe-4b9f-84c0-32e835bb4ade

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861