# FDA WARNING_LETTER - Atossa Genetics, Inc. - July 25, 2012

Source: https://www.keypedia.com/records/warning_letter/atossa-genetics-inc/f8da5c5f-42c0-4627-94e6-63b1eb450f32

> FDA WARNING_LETTER for Atossa Genetics, Inc. on July 25, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Atossa Genetics, Inc.
- Inspection Date: 2012-07-25
- Product Type: Devices
- Office Name: Seattle District Office
- Summary: On July 16-25, 2012, an FDA inspection of Atossa Genetics in Seattle, Washington, revealed their MASCT System and Collection Kit devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with cGMP requirements of 21 CFR Part 820. The firm's August 6, 2012, response to the FDA 483 was deemed inadequate.

Violations included:
1.  Failure to establish and maintain design control procedures (21 CFR 820.30(a)).
2.  Failure to establish and maintain procedures for design changes, with undocumented changes to the MASCT System filter and lack of design inputs/outputs/verification for current changes (21 CFR 820.30(i)).
3.  Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)).
4.  Failure to maintain adequate complaint files and procedures, with unfiled complaints regarding MASCT System funnel thread breakage (21 CFR 820.198(a)).
5.  Failure to maintain adequate records of complaint investigations, lacking required information (21 CFR 820.198(e)).
6.  Failure to establish and maintain adequate requirements for suppliers, contractors, and

## Related Officers

- [District Director](https://www.keypedia.com/people/charles-m-breen/ea1c624f-6943-4e12-b826-4cffbf358220)

Company: https://www.keypedia.com/companies/atossa-genetics-inc/e4f9a07e-c419-4996-8f35-d9ce60a1916c

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913