# FDA 483 - KP Pharmaceutical Technology - March 21, 2024

Source: https://www.keypedia.com/records/483/kp-pharmaceutical-technology/628e29b7-d44e-4256-871b-533310be9904

> FDA 483 for KP Pharmaceutical Technology on March 21, 2024. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KP Pharmaceutical Technology
- Inspection Date: 2024-03-21
- Product Type: devices
- Office Name: Detroit District Office
- Summary: An FDA inspection of BioDerm, Inc., a medical device manufacturer in Largo, FL, conducted from April 8 to April 18, 2024, revealed significant deficiencies in its quality system, particularly concerning its Liberty device. The firm received a Form FDA 483 detailing four key observations indicating non-compliance with the Quality System Regulation (21 CFR Part 820).

Primary issues included inadequate corrective and preventive action (CAPA) procedures, which lacked requirements for verifying the effectiveness of actions taken. This led to recurring problems like adhesive transfer and leaking catheters, with multiple CAPAs closed without confirming resolution, a repeat observation from a previous inspection. Additionally, the complaint handling system was found deficient, failing to ensure timely processing or adequate evaluation for potential Medical Device Reporting (21 CFR Part 803). The company's procedure allowed up to 30 days to initiate complaint records, potentially delaying critical safety assessments.

Further observations noted insufficient design validation procedures for the Liberty device. Its clinical evaluation was based on a single subject over two weeks, lacking statistical analysis or real-world stress testing. Lastly, the firm had not established or validated process control procedures for the Liberty catheter manufacturing, relying solely on visual inspection which may not adequately detect all defects, such as leaks. BioDerm, Inc. is required to address these observations to ensure compliance with regulatory standards and uphold product quality and patient safety.

## Related Documents

- [483 - 2023-02-03](https://www.keypedia.com/records/483/kp-pharmaceutical-technology/af93ffc6-90c2-4cba-8eba-f8fa21b7a395)
- [483 - 2024-03-11](https://www.keypedia.com/records/483/kp-pharmaceutical-technology/173fdef4-ac0a-4d24-b45a-3209f2cd0614)
- [483 - 2024-03-21](https://www.keypedia.com/records/483/kp-pharmaceutical-technology/c774dd17-c5c5-4769-9d75-e5911bfefd41)

## Related Officers

- [Gregory Stone](https://www.keypedia.com/people/gregory-stone/6fc15653-2d1b-46d6-89dd-655a40ea72de)
- [David V. Ward](https://www.keypedia.com/people/david-v-ward/14bb7fc5-296b-4d14-bd3e-4c6ce5ac5cc2)
- [John R. Gridley](https://www.keypedia.com/people/john-r-gridley/32a64db5-8914-4eb2-93ea-e41da190edd7)
- [company_representative](https://www.keypedia.com/people/michael-correa/52d11b7e-2372-4052-9998-2ce9a0382d65)
- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.keypedia.com/companies/kp-pharmaceutical-technology/acd7d203-2bd2-4702-a902-83c45f57890f

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03