FDA 483 - True Function Laboratory, Inc. - August 07, 2023

On August 10, 2023, the FDA issued a Form 483 to True Function Laboratory, Inc., a manufacturer located at 7851 University Ave Ste 102, La Mesa, CA. The inspection, conducted from July 31 to August 7, 2023, by Investigator Juanj Wu, identified seven observations related to quality system deficiencies.

**Key Observations:**

1. **Complaint Handling:** Not all complaints were reviewed and evaluated for investigation necessity. Eight of eleven reviewed complaints lacked documentation of decision-makers and reasons for not investigating. Three complaints had no investigation status. Root cause investigations were missing for specific device fractures and screw detachments. All eleven complaints lacked Medical Device Report (MDR) evaluations and CAPA needs documentation.

2. **Equipment Calibration and Inspection:** Procedures for equipment calibration and inspection were inadequate. A scale lacked calibration and identification labels. A 3D scanner's serial number in the log did not match the device. An "out of service" 3D scanner lacked a proper tag.

3. **Nonconforming Product Control:** Procedures for controlling nonconforming product were not established. Eleven nonconforming records for anti-snoring and anti-obstructive sleep apnea devices lacked required investigation documentation.

4. **Device History Records (Repeat Observation):** Procedures for device history records were inadequate. Eleven reviewed device history records for anti-