A company recently received this 483 observation: …..Document control procedures have not been adequately established. […]
Dina Kisver
Are your consultants listed on your approved vendor list? A company recently received this 483 […]
A company recently received this 483 observation: …..There was a failure to handle and store […]
Are they password protected? A company recently received this 483 observation: …..Supervisory oversight over the […]
Are you performing the verification in a timely manner? A company recently received this 483 […]
Are you inspecting your glassware for defects? A company recently received this 483 observation: …..Laboratory […]
A company recently received this 483 observation: …..Laboratory controls do not include the establishment of […]
Are you keeping a log of the documents that are being destroyed? A company recently […]
21 CFR 820.22 states: Quality audits shall be conducted by individuals who do not have direct […]
Are you evaluating their capabilities prior to using them? An API facility recently received this […]