# FDA 483 - Ladd Family Pharmacy LLC - July 30, 2019

Source: https://www.keypedia.com/records/483/ladd-family-pharmacy-llc/9925a317-55fb-4eca-898b-2d1904a0af02

> FDA 483 for Ladd Family Pharmacy LLC on July 30, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ladd Family Pharmacy LLC
- Inspection Date: 2019-07-30
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: This FDA Form 483 document outlines observations made during an inspection of a drug manufacturing facility. The facility is cited for several violations related to drug product formulation, water quality, and equipment cleaning.

Specifically, the inspection found that a non-pharmaceutical grade component was used in the formulation of a drug product. Additionally, the facility failed to demonstrate that the water used as a component of aqueous drug products meets the minimum requirements for USP Purified Water. An example provided is the use of (b)(4) water as a component for Acetaminophen Free 12mg/mL Liquid lot number 07102019:66@26.

Furthermore, the facility produced hazardous drugs without providing adequate cleaning of work surfaces and utensils to prevent cross-contamination. Finally, the inspection noted a failure to adequately clean non-dedicated equipment; for instance, an oxidizing agent was not used to clean non-dedicated equipment after compounding a testosterone-containing product. These observations indicate deficiencies in quality control and manufacturing processes that could impact product safety and efficacy.

## Related Documents

- [483 - 2016-09-23](https://www.keypedia.com/records/483/ladd-family-pharmacy-llc/5e83f8bf-5f8a-46d2-a306-15d33cae99b9)
- [WARNING_LETTER - 2016-09-23](https://www.keypedia.com/records/warning_letter/ladd-family-pharmacy-llc/dcc60126-64eb-49b6-87b7-0591ae5ebc7f)
- [483 - 2019-07-30](https://www.keypedia.com/records/483/ladd-family-pharmacy-llc/bfdada52-96d2-4e14-9810-9ab8d011ebfa)

## Related Officers

- [Investigator](https://www.keypedia.com/people/joshua-p-wireman/1f5cca58-4a35-4b1a-b344-35820b1e58fb)

Company: https://www.keypedia.com/companies/ladd-family-pharmacy-llc/2f96e239-c8d1-4fa0-93af-495a0c93f1ed

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913