# FDA 483 - TSDR Pharmacy Inc. dba brandMD Skin Care - March 28, 2017

Source: https://www.keypedia.com/records/483/tsdr-pharmacy-inc-dba-brandmd-skin-care/21c212da-dba4-4927-9da6-687102afc93b

> FDA 483 for TSDR Pharmacy Inc. dba brandMD Skin Care on March 28, 2017. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: TSDR Pharmacy Inc. dba brandMD Skin Care
- Inspection Date: 2017-03-28
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 documents observations from an inspection of a facility preparing drug products in a pharmacy room.

**Key Violations and Observations:**

1.  **Inadequate Laboratory Controls:**
    *   No specifications or test procedures for critical attributes of drug products prepared in the pharmacy room.
    *   No assay specifications for any drug products.
    *   No established test procedures for Color, Odor, Appearance, pH, and Viscosity tests for drug product release.
    *   Homogeneity of prepared bulk drug products was not demonstrated.

2.  **Absence of a Quality Control Unit (QCU):**
    *   No QCU or designated person with responsibility and authority to approve/reject components, containers, packaging, labeling, and drug products.
    *   SOP No. A-07, Compounding Quality Assurance, defines QCU responsibility but no QCU exists.
    *   No procedures or quantitative analyses for potency testing of prepared drug products to support label claims.
    *   Pharmacist-in-Charge (PIC) performs all drug preparation activities, and these activities are not reviewed or verified by a second person.
    *   Completed Formulation and Batch Compounding Records (FBCR) are approved by the PIC himself, without review by an independent quality person.
    *   Active Pharmaceutical Ingredients (APIs) (Hydrocortisone, Hydroquinone, Retinoic Acid/T

## Related Officers

- [Professor](https://www.keypedia.com/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)

Company: https://www.keypedia.com/companies/tsdr-pharmacy-inc-dba-brandmd-skin-care/15e8d1a1-c590-40f3-974f-37a1a7d94e17

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b