# FDA 483 - Tower Pharmacy and Compounding - September 19, 2019

Source: https://www.keypedia.com/records/483/tower-pharmacy-and-compounding/33ed7a6b-ee8d-4cce-add1-b7f89ca81900

> FDA 483 for Tower Pharmacy and Compounding on September 19, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tower Pharmacy and Compounding
- Inspection Date: 2019-09-19
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: During an inspection conducted by the FDA from September 9 to September 19, 2019, Tower Pharmacy and Compounding of Mission Viejo, California, received a Form FDA 483 detailing significant observations. The inspection revealed two primary areas of concern related to drug compounding practices, implying deviations from appropriate manufacturing standards. Firstly, the FDA noted inadequate controls to prevent cross-contamination, particularly concerning highly potent drug products. Inspectors observed that non-dedicated compounding equipment, including a worn mixing set and a spatula with an unsealed wooden handle, were used for sensitive formulations like Testosterone gel. These tools were subjected to insufficient cleaning methods (e.g., commercial dishwashing detergent) and stored on soiled surfaces, with no assurance that active pharmaceutical ingredients were not transferred between products. Additionally, the Pharmacist-in-Charge was observed compounding with his beard exposed, compromising personnel hygiene and sterility. Secondly, the firm was found to be routinely using non-pharmaceutical grade components in the formulation of multiple drug products. This practice was noted across various compounded gels and creams, including those containing Lidocaine-Tetracaine, Testosterone, and dermatological agents, raising concerns about the purity, safety, and efficacy of the final drug products. Tower Pharmacy and Compounding is required to address these inspectional observations by evaluating their processes and implementing comprehensive corrective actions to ensure product quality, patient safety, and full compliance with federal regulations governing drug compounding.

## Related Documents

- [483 - 2019-09-19](https://www.keypedia.com/records/483/tower-pharmacy-and-compounding/9cd24748-a1a1-4149-a8a4-cd23d64c75ab)
- [145 - 2020-08-11](https://www.keypedia.com/records/145/tower-pharmacy-and-compounding/41b7443a-ed35-4e5d-8277-b0c2bc909fe7)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/tower-pharmacy-and-compounding/3c9b4043-5443-4233-b332-44be76bdd719

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