# FDA 483 - Algunas Inc., dba Woodland Hills Compounding Pharmacy - October 11, 2018

Source: https://www.keypedia.com/records/483/algunas-inc-dba-woodland-hills-compounding-pharmacy/94b48ccc-8702-4816-9b00-b47f5d5f3073

> FDA 483 for Algunas Inc., dba Woodland Hills Compounding Pharmacy on October 11, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Algunas Inc., dba Woodland Hills Compounding Pharmacy
- Inspection Date: 2018-10-11
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 was issued to Algunas Inc., dba Woodland Hills Compounding Pharmacy, located at 20631 Ventura Blvd Ste 305, Woodland Hills, CA 91364-2352. The inspection, conducted from October 4-11, 2018, identified the firm as a producer of non-sterile drugs. Steven A. Levin, Pharmacist-In-Charge / Owner / CEO, was the recipient of the report.

The sole observation noted was the use of a non-pharmaceutical grade component in drug product formulations. Specifically, since 2017, the firm used a non-USP grade water system, which was not routinely tested for production quality and contamination risks. This non-pharmaceutical grade water was used in the preparation of numerous non-sterile drug products, including:

*   **Topical Facial Pads:** Tonical Facial Pads, Clear Face Pads (Salicylic Acid 2%, Sulfacetamide 5%, Clindamycin 0.5%), Daily Facial Peel (Pads) (Glycolic Acid 1%, Salicylic Acid 1%, Lactic Acid 3%), Skin Lightening Pads (Hydroquinone 4%, Kojic Acid 4%, Lactic Acid 7%), Ultra Complexion Pads (Glycolic Acid 10%, Salicylic Acid 5%).
*   **Topical Facial Solutions:** Glycolic Acid Sol

## Related Documents

- [483 - 2016-04-29](https://www.keypedia.com/records/483/algunas-inc-dba-woodland-hills-compounding-pharmacy/9d762d2f-1899-48d1-88e6-e77a9e173fcd)
- [WARNING_LETTER - 2016-04-29](https://www.keypedia.com/records/warning_letter/algunas-inc-dba-woodland-hills-compounding-pharmacy/70e5d12d-f098-4c8a-b67e-7c634856b0d1)
- [483 - 2018-10-11](https://www.keypedia.com/records/483/algunas-inc-dba-woodland-hills-compounding-pharmacy/6dd6fe35-089d-42a9-b2aa-46e310c026ed)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.keypedia.com/companies/algunas-inc-dba-woodland-hills-compounding-pharmacy/8c9df046-28e2-4a7a-81c0-655992746d7e

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