FDA Letter API

H. A. R. Maspeth Corp.

Letter data

Company
H. A. R. Maspeth Corp.
Recipient
H. A. R. Maspeth Corp. | United States
Issue date
2018-04-24
Posted date
Not available
FDA office
United States
Subject
Not available
Product
Not available
CMS ID
434429
Reference number
Not available
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: None found

21 U.S.C.: None found

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER H. A. R. Maspeth Corp. MARCS-CMS 434429 — April 24, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: H. A. R. Maspeth Corp. United States Issuing Office: United States Office of Human and Animal Food Operations East Division 1 VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED April 24, 2018 Ms. Elizabeth Kwon, President/Owner H.A.R. Maspeth Corp. 44-28 55th Avenue Maspeth, NY 11378-1042 Dear Ms. Kwon: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2014-48, issued on July 22, 2014. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CDR Catherine Beer Director, Compliance Branch Office of Human and Animal Food Operations East Division 1 Content current as of: 04/25/2018