A summary of what this company's regulatory affairs manager discussed about their company's experiences:
- 'Inspectors are calling these ‘routine FSMA inspections' and are not distinguishing between Preventive Controls and modernized GMP inspections'
- These audits are generally more focused on high-risk products.
- Auditors had visited 7 of these audits - one full Preventive Controls inspection and six modernized GMP audits.
- Generally there are three inspectors.
- Audits have lasted 1 to 5 days, mostly 4 to 5 days.
- Four of the seven audits included swabathons (100 to 150 swabs), which included Zone 1 (30%), Zone 2 (20%) and Zone 3 (50%). No zone 4.
- There is a focus on the company's environmental monitoring program including the records and corrective actions on positvie results.
- With regard to verification activities, they are focusing on records including corrective action logs, production schedules, sanitation records, and calibrating inspection equipment records.
- With regard to the Preventive Control plan, inspectors are reviewing the hazard analysis with questions on the justification behind each of the identified hazards.
- There is also a review of the written recall plan.
- Recently there is attention on the supply chain program.
- Review of handling of byproducts used for animal feed, consumer complaint handling, and FSPCA training looking for certificates of completion.
An interesting item in the article is that FDA will want to take photos in the facility, so a company needs to have a policy to address this. The same goes with photocopying records.