Aware Products Inspection Records

*** This is an automated message. Please do not reply to this email. ***
Reference: FDA2062531
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

Anna Merlan Anna Merlan
Re: Confirmation # FDA2062531
Requester Ctrl #:
In Reply refer to: 2020-1353
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
: All files, reports, follow up materials, references to other agencies, and any other related materials regarding the inspection of Aware Products LLC, a company in the LOS district whose inspection end date is given in the Inspection Classification Database as 11/16/18. The inspection is listed as being in the project area of Drug Quality Assurance.
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm.

Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-day time limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the complexity of your request and whether sensitive records, voluminous records, extensive search, and/or consultation with other HHS components or other executive branch agencies are involved. Please note that requests for medical device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process.

If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at 301-796-8982 or write to us at:
Division of Freedom of Information,
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
Fax: 301-827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
and/or:
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov
Office of Government
Information Services
National Archives and Administration
8601 Adelphi Road - OGIS
College Park, MD 20740-6001
Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-Mail: ogis@nara.gov
Fax: 202-741-5769 Note: Do NOT reply directly to this E-mail

Good Morning,
Please see the attached response letter and record for FOIA# 2020-1353. Thank you.

Mariah Jackson
Government Information Specialist
FOIA West (Branch II)
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning and Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U. S. Food and Drug Administration
Phone: 303-236-9703
6th Ave. and Kipling St. Bldg 20
Denver, CO 80225

[cid:image008.png@01D2D2FA.8C9AFC30]
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>