5-item 483 handed to Sunoptic for unvalidated processes.

Sunoptic Technologies, Jacksonville, FL, Maitland, FL, District

Sunoptic Technologies, Jacksonville, FL, received a five-item 483 in a 2007 GMP audit because certain processes were not validated and approved according to established procedures. Conducting the audit for the Maitland, FL, District Office was investigator Leo Lagrotte.

The EIR stated that Sunoptic is a Class II manufacturer of surgical illuminator medical devices. The company also is a contract manufacturer of fiberoptic glass dental probes used for polymerization of dental adhesives.

"When moving to your new administration and production facilities on April 26, 2004, your firm failed to perform required process validations for automated clad fiber manufacturing process on your two fiber wheel operations.

When asked for the validation protocol and actual validation summary, management stated that the firm did not collect a validation of the piece of equipment in question, including all parameters within the tolerances used during the process. They agreed that validation should be performed and had "no issues with performing a retrospective validation to commence within a week," the documents stated.

Next, device history records (DHRs) were found to be faulty, in that a review of 20 DHRs for finished fiber optic cables and light sources for five DHRs were found to be incomplete. For example, in the 20 DHRs reported, the inventory control department failed to document issuance of parts required on the "pick list" or failed to enter an "N/A" where appropriate when parts were not required. Quality control also did not document these deviations before final release of the finished device to inventory or shipping.

Also the DHRs did not include the primary identification label and labeling for each device, FDA records stated. "Specifically, the firm failed to follow their DHR procedure which requires under section 5.15 that the primary information label be part of the DHR as required by FDA regulations."

The EIR also noted "the quality control department should have discovered the missing information during their DHR review before release and should have ensured that all DHRs were complete."

Further, the 483 stated that documentation reviewed during the audit did not show that management with executive responsibility had participated in management reviews. For example, the company did not include information in the management review procedure in its quality manual as to which management with executive responsibility were required to attend annual management review meetings. In addition, no provision was made for replacement procedures should a required attendee be unable to attend the management review meeting.

Last, the report determined that the dates of quality audit had not been documented. "Specifically, your firm reported internal audit completion for 2005 and 2006, but failed to document that the management review subsystem of the quality system was audited during those quality audits."

The investigator reviewed the company's corrective and preventive action (CAPA), complaint and MDR procedures and had no major observations.

The FDAer stated during close out that the firm classified its dental probes as medical devices. Management agreed "that if the firm was selling the dental probes to distributors and end users that a 510(k) would be required since the dental probes are classified as accessories to a Class II device and have a Class II designation as well," the EIR stated.

The investigator warned the company that the dental probes sold to anyone other than the OEM manufacturer contracted to receive the probes, was a violation of the FD&C Act and all devices could be deemed adulterated under the law.

One verbal observation in the 483 noted that the firm failed to list and obtain FDA clearance before shipping finished devices to distributors and end users. The FDAer also objected to the finished devices being shipped unlabeled.

Sunoptic Technologies, Jacksonville, FL, 3/19-22/07, Doc. 110001M, $14 plus retrieval.