483 Roundup: FDA Cites Three Firms for Reporting, Documentation Issues
Repro-Med Systems in Chester, N.Y. failed to submit a report to the FDA on steps taken to reduce a health risk posed from a device, inspectors found during a late 2016 inspection.
In a Form 483, the agency said the facility also lacked adequate quality procedures and documentation.
Defects in a supplier’s product led to a 2016 product recall in which customers were notified of the problem. Repro-Med requested the products be returned to the company for disposal, but did not notify the FDA.
The company also failed to follow proper quality procedures after a design change, with no documented validations to confirm that the changes would not negatively impact the product or packaging.
Inspectors also found inadequate CAPA investigations for various sterilization procedures, as well as a lack of procedures for intake and documentation of defective product; no documentation for rework and reevaluation activities in the device history record, specifically for needles; inadequate testing verification for manufacturing equipment; and a lack of quality records for suppliers.
The FDA also faulted the facility over its procedures for receiving, reviewing, and evaluating complaints. Between July 2015 and the inspection, three complaints were not evaluated, and the firm’s procedures for complaint investigations did not include collecting all information related to adverse events.
In one case, the facility received a complaint noting that similar malfunctions had occurred previously, but the firm failed to follow up on the reports. A separate complaint about tubing malfunctions listed specific lot numbers that were affected but the firm did not properly investigate the lots in question, the agency said.
The See Clear Company: The FDA found extensive problems with documentation and quality procedures during a fall 2016 inspection of The See Clear Company in Norcross, Ga., resulting in a 12-observation Form 483.
Inspectors found the company did not have procedures for evaluating and investigating complaints, and there was no process or file system for dealing with or documenting complaints. The facility also lacked adequate procedures for: dealing with incoming product, including their acceptance or rejection and personnel training documents; and procedures for control and distribution of finished devices.
None of the quality documents the inspectors found were signed or dated. The documentation also lacked procedures for identifying, segregating and disposing of defective products. The facility provided no quality agreements with contractors outlining their roles and responsibilities. The firm was unable to produce a quality agreement clearly establishing the agreed-upon roles and responsibilities between contractors and the company, and lacked adequately documented monitoring of the company’s contract manufacturer.
Risk analysis, specifically for the shelf life of the product, was also found to be inadequate. The company’s CAPA procedures did not include a plan for verifying or validating corrective or preventative actions or for recording and implementing changes, the agency said. Moreover, the firm only provided data for one shelf-life, and was unable to justify all components of its risk analysis.
The facility had no documentation of quality audits for 2014, 2015 or 2016, and managers did not assess its quality system for suitability and effectiveness at required intervals.
Eptam Plastics: Contract medical device manufacturer Eptam Plastics in Northfield N.H., was found to have problems with handling complaints and was issued a Form 483 following a February 2017 FDA inspection.
The inspectors found the facility had not been properly maintaining records of evaluations, investigations, and complaint determinations, and had not properly documented the process for dealing with complaints.
Read the Form 483s here: www.fdanews.com/05-12-17-Three483s.pdf. — Gayle S. Putrich