Drug manufacturers must comply with FDA drug current Good Manufacturing Practices (cGMPs) which exist to ensure drug safety, identity, strength, quality, and purity. Eventually, FDA will inspect your facility for compliance with GMPs and other requirements. We can help refine your GMPs  and help you respond to FDA inspections. cGMPS Drug GMPs are the main target of FDA investigators when they inspect a drug manufacturing facility. Drug GMPs consist of a variety of controls mostly dedicated to sanitation and ensuring drug  identity, strength, quality, and purity. These include quality management systems, personnel qualification, facilities & equipment, raw material acquisition, operating procedures, detecting and investigating quality deviations, and reliable testing laboratories. Inspections Once the FDA decides to inspect your drug facility, you are legally required to allow them to enter and inspect. So, you must be prepared. Here are a few pointers for an FDA inspection:

• FDA has authority to enter your facility at reasonable times to inspect.
• FDA has the authority to sample products for testing. If they do, they will issue a Receipt for Sample (Form 484).
• FDA has authority to inspect and copy your records related to compliance.
• FDA does not have authority to inspect financials, sales, pricing information, or personnel data not related to a required qualification.
• You are not required to sign FDA documents.
• FDA will find flaws in your GMPs and compliance. FDA will note your non-compliance as “observations” in the 483 Inspectional Observations Report. You must respond to the observations in writing and correct the issues noted in the observations.