Berkeley Biologics LLC

Form 483

Richmond, California, United StatesFEI 1000100754Issued September 25, 2023

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1000100754.

Observations5

Issue DateSeptember 25, 2023

StatusNo Warning Letter

Related Inspections5

Establishment Details

Firm: Berkeley Biologics LLC
Location: Richmond, California, United States
FEI Number: 1000100754
Product Type: Biologics
Issue Date: September 25, 2023
Country: United States

Inspection History, 2012 to 2023

NAI3

VAI1

OAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Berkeley Biologics LLC FDA Form 483, Richmond, California, September 25, 2023