# FDA 483 - Compound Preferred LLC - August 01, 2019

Source: https://www.keypedia.com/records/483/compound-preferred-llc/8b6d495f-8b79-495b-8ade-3ca5e95ce9a6

> FDA 483 for Compound Preferred LLC on August 01, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Compound Preferred LLC
- Inspection Date: 2019-08-01
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: RAM Pharma, Inc., an outsourcing facility, was subject to an FDA inspection from July 16 to August 1, 2019, resulting in an FDA 483 document detailing several significant deficiencies. The inspection revealed inadequate control over aseptic processing areas, with environmental monitoring systems cited for insufficient sampling, failure to investigate microbial growth, and absence of air quality alarm systems. The firm also lacked proper validation for aseptic and sterilization processes, including load mapping studies for biological indicators, depyrogenation for glassware, and efficacy data for preservatives in multi-dose products. Deficiencies extended to cleaning and disinfection protocols, where non-sterile wipes were used in critical areas. Furthermore, RAM Pharma, Inc. was found to have no comprehensive stability testing program, failing to conduct potency testing for products with extended 'Beyond Use Dates' and lacking data to support such extensions. Critical finished sterile drug products were distributed without testing for pyrogens or potency. Notably, several of these issues, including environmental monitoring, preservative efficacy, endotoxin testing, and potency testing, were repeat observations from previous inspections, indicating a pattern of non-compliance. The company also failed to establish alert levels or adequately investigate repeated microbial incursions into critical aseptic zones. RAM Pharma, Inc. is required to implement robust corrective actions to resolve these deviations and ensure the quality and safety of its sterile drug products.

## Related Documents

- [483 - 2017-03-01](https://www.keypedia.com/records/483/compound-preferred-llc/2cb56dff-6dd8-4e94-9589-fdc271871fa9)
- [483_RESPONSE - 2017-03-01](https://www.keypedia.com/records/483_response/compound-preferred-llc/0913ec67-3f8d-46ce-96f1-8444c3be3e62)
- [WARNING_LETTER - 2017-03-01](https://www.keypedia.com/records/warning_letter/compound-preferred-llc/d7d4a707-3d72-4915-bda4-bc79715216e7)
- [483 - 2019-08-01](https://www.keypedia.com/records/483/compound-preferred-llc/5d40fe4e-e577-4b81-9059-578d4c7cd1a3)
- [483 - 2021-12-17](https://www.keypedia.com/records/483/compound-preferred-llc/6e16267f-c12e-46a1-87a5-454c861549fe)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/compound-preferred-llc/0137c1b7-e3ba-45ff-9fda-c53b21b0b857

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