Failure to document numerous activities including validation, corrective and preventive actions, process changes and others landed Hyperbaric Technologies a Form 483 following a Sept. 19-26, 2018, inspection of its Amsterdam, New York, manufacturing facility.
The manufacturer of hyperbaric chambers and mountain bags failed to document process validation activities and results such as the sealing process for its Gamow nylon hyperbaric bags.
Also missing was documentation for corrective and preventive activities. The FDA said the devicemaker implemented design changes but a CAPA report wasn’t maintained to show a description of records revised such as engineering drawings and a bill of materials to show changes were effective.
The FDA noted that batches released with the modifications displayed small tears near the seal.
The firm’s device history record lacked evidence that relief valves were tested as outlined in the firm’s standard operating procedures, and the DHRs for all products lacked evidence of leak test results.
The FDA inspector found a device master record was not maintained and testing protocols were incomplete with numerous specifications missing.
Read the Hyperbaric Technologies Form 483 here: www.fdanews.com/04-11-19-hyperbarictechinc483.pdf.