America’s Blood Centers (ABC) submitted these formal comments to the Food and Drug Administration (FDA) in response to a draft guidance on responding to FDA Form 483 observations at the conclusion of a drug CGMP inspection.
ABC supports FDA’s draft guidance on responding to Form 483 observations and appreciates its focus on effective corrective actions and blood supply safety. However, ABC recommends FDA clarify that certain response elements (such as a table of contents, executive summary, attachments, global investigation plans, and communication plans) should be optional and used only when applicable, as they are often unnecessary for routine blood center inspections. ABC also urges FDA to consider allowing a voluntary “letter of intent to respond” so establishments can formally notify FDA of their plan to submit a full response when a Form 483 is issued.