Apira Science, Inc. – FDA Warning Letter, Sep 29, 2011
On April 17, 2012, the FDA issued a Warning Letter to Apira Science, Inc. following an inspection from August 16 to September 29, 2011. The inspection revealed that the iGrow Hair Rejuvenation System and Revage 670 Laser System are devices under the Federal Food, Drug, and Cosmetic Act.
The iGrow Hair Rejuvenation System was found to be adulterated under section 501(h) of the Act, as its manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820). Apira Science's initial responses, asserting iGrow is not a device and thus not subject to 21 CFR Part 820, were deemed inadequate. Subsequent responses were not reviewed due to late submission.
Key violations include: 1. **Failure to control device design (21 CFR 820.30):** No established design and development plans, no design history file (DHF) for iGrow, and no documented design validation for iGrow software. 2. **Failure to maintain a device master record (DMR) (21 CFR 820.181):** No DMR for the iGrow Hair Rejuvenation System. 3. **Failure to establish incoming product acceptance procedures (21 CFR
ID · f104d575-9c1b-46c3-bec8-c28dc7206e2d
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