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FDA Sample

This certificate certifies that Aikyam Enterprises, located in Lucknow, India, complies with FDA regulatory guidelines for manufacturing and trading medical devices and equipment. The scope of certification includes products like masks, gloves, disinfectants, ventilators, and more. QCAS has reviewed Aikyam Enterprises' technical documents and procedures and found them to meet FDA requirements. The certificate is valid for three years subject to annual compliance audits.

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Preeti Jaiswal
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2K views1 page

FDA Sample

This certificate certifies that Aikyam Enterprises, located in Lucknow, India, complies with FDA regulatory guidelines for manufacturing and trading medical devices and equipment. The scope of certification includes products like masks, gloves, disinfectants, ventilators, and more. QCAS has reviewed Aikyam Enterprises' technical documents and procedures and found them to meet FDA requirements. The certificate is valid for three years subject to annual compliance audits.

Uploaded by

Preeti Jaiswal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

This is to certify that the

AIKYAM ENTERPRISES
F - Block, 335/P
P-1-6,
6, Rajajipuram, Lucknow, Uttar Pradesh - 226017, India
has been assessed by QCAS and found to
comply with the requirements of:

FDA
(U.S.
U.S.FDA
FDA Regulatory Guidelines for Scientific
and Medical Instruments))
For the following scope:
“MANUFACTURING AND TRADING OF DISINFECTANT, SANITIZER, GOGGLES, PPE KIT, FACE SHIELD,
GLOVES, NITRILE GLOVES,DISPOSABLE NEEDLE, SANITARY PAD, DIAPER, 3 PLY MASK, N95 MASK, KN95
MASK, 6 PLY MASK, HEAD CAP, V VENTILATOR
ENTILATOR AND TUBE, SANITAIZATION TUNNEL, SURGICAL,
ORTHOPEDIC IMPLANT, REHABILITATION PRODUCTS, FRUIT & VEGETABLE WASHER, ETO
SANITIZATION CHAMBERS & UV SANITIZATION CHAMBERS AND AUTOMATIC SANITIZER DISPENSER ”

The Technical Document maintained by the orgorganization


anization has been reviewed and found to comply
with the requirement and found to comply with the requirements of section 701(h)(1)(C)(i) of the
U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)).
10.115(g)(2))
Note : This certificate is issued on the basis of assessment carried out as per technical
specifications. The testing analysis is verified by random sample & this certificate does not assure
quality in regular production
production.
Certificate Number: QCAS-AKES-20-050243050243
To verify this certificate
cate please visit at www.gaafs.us
Date of Certification 18th May 2020
Issuance Date 18th May 2020
1st Surveillance Due 17th May 2021
2nd Surveillance Due 17th May 2022
Re-Certificate Due 17th May 2023

Authorized Signatory

Validity of this Certificate is subject to Annual Surveillance audits done successfully


This certificate remains the property of QCAS and must be returned whenever demanded QCAS is
an independent system product and personal assessment body QCAS is accredited by

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