When was your last FDA visit? Our last FDA visit occurred from March 31, 2023, through April 13, 2023, under 7356.002 and 7656.002F. This covered both Finished Drug dosage and API under a Full Surveillance Audit due to the addition of our new facility at 400 Crossroads Pkwy, Bolingbrook, IL 60440, along with our existing facility located at 1319 Marquette Drive, Romeoville, IL 60446. Both facilities share the same FDA Establishment Identification (FEI) number, 3003574860.
Did you pass the audit? Yes – though the FDA does not communicate “PASS” or “FAIL” in an audit report. Instead, the FDA classifies a facility as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). No Official Actions (OFI) were indicated as a result of our audit. Both “No Action Indicated” and “Voluntary Action Indicated” are what organizations commonly refer to as a “Pass.”
Did you receive any 483’s? Yes, 2 nonconformances (NCR) were noted. These NCR are classified as Voluntary Action Indicated (VAI), which means minor objectionable conditions or practices were found, but the FDA did not take or recommend any administrative or regulatory action based on the findings. We have responded to these observations with corrective actions as outlined below.
What were the 483’s for?
- [Element #6] Lab computer security login process
- [Element #3] Supplier qualification for purchased Purified Water as an ingredient
Have the 483’s been addressed? Yes. These were addressed by 4/28/23.
Was my product affected? Even though the FDA covers all products manufactured by Nanophase Technologies Corporation, including all Solésence products, none of the products were specific to the audit nor affected under FDA action.
When will you have the final report? The FDA has issued the Establishment Inspection Report, or EIR, and determined that this audit has been closed. All associated CAPA initiated based on the 483 are being completed.
Can I have a copy of the report? A summary report of the EIR can be provided upon request. Due to the confidential nature of customer– and business-related information contained in EIR, a redacted copy of the EIR can be obtained through a FOIA request to the FDA. Please note the redaction is based on FDA discretion, in line with their policies.
Why did the FDA visit? By law, the FDA is required to audit all drug manufacturing facilities in the USA in a periodic fashion, normally in a 2–4-year cycle. The audit is either Abbreviated or Full Surveillance. This audit was a Full Surveillance Audit covering all 6 segments of cGMP, which includes the following:
[1] Quality System;
[2] Facilities and Equipment System;
[3] Material System;
[4] Production System;
[5] Packaging and Labeling System; and
[6] Laboratory Control System
Is there any follow-up to the FDA Audit? A response to observations with corrective actions was prepared and submitted to address the 2 nonconformities that were issued under 483. Nanophase Technologies Corporation submitted the CAPA for FDA review and approval before the response deadline. The FDA has not requested further review and /or changes to the CAPA Nanophase submitted.