ADMA Adma Biologics

Filed: 20 Jul 21, 4:31pm

Washington, D.C. 20549



Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 20, 2021

(Exact name of registrant as specified in its charter)

(State or other jurisdiction of incorporation)(Commission File Number)(IRS Employer Identification No.)
465 State Route 17, Ramsey, New Jersey07446
(Address of principal executive offices)(Zip Code)

Registrant’s telephone number, including area code: (201) 478-5552
(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock
Nasdaq Global Market
Preferred Share Purchase Rights
-Nasdaq Global Market

Item 8.01Other Events

On July 20, 2021, ADMA Biologics, Inc. (the “Company”) issued a press release announcing that the United States Food and Drug Administration (“FDA”) recently completed a Pre-Approval Inspection (“PAI”) of the Boca Raton, FL manufacturing facility related to the Company’s application for its VanRx SA25 Workcell aseptic fill-finish machine (“VanRx”).  The PAI successfully concluded with the FDA issuing zero Form 483 observations in the FDA’s determination that the Company’s Boca Raton, FL manufacturing facility continues to operate in compliance with the principles and guidelines of Good Manufacturing Practices standards.  A full copy of the press release it attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference herein.

Item 9.01Exhibits.

(d) Exhibits

Exhibit No.Description

ADMA Biologics, Inc. Press Release, dated July 20, 2021



Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

July 20, 2021ADMA Biologics, Inc.
 By:/s/ Brian Lenz
  Name:Brian Lenz
  Title:Executive Vice President and Chief Financial Officer