FDA 483 - Professional Disposables International, Inc. - June 23, 2021

Professional Disposables International, Inc. received an FDA Form 483 citing significant deficiencies across its manufacturing operations. Observations included widespread failures in out-of-specification investigations, inadequate quality control unit procedures, and a failure to submit a required Field Alert Report. The inspection also highlighted issues with laboratory controls, process validation, and equipment design, indicating a systemic lack of adherence to cGMP requirements.