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  5. VUAB Pharma a.s. - Close Out Letter 3/7/16
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CLOSEOUT LETTER

VUAB Pharma a.s. Mar 07, 2016

VUAB Pharma a.s. - Close Out Letter 3/7/16


VUAB Pharma a.s.

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
 Office of Manufacturing Quality
Division of Drug Quality II
Global Compliance Branch 4
10903 New Hampshire Avenue
Building #51, Room 4220
Silver Spring, MD 20993

TELEPHONE: (301) 796-3759
             FAX: (301) 847-8742

March 07, 2016

Jan Mengler, General Manager
VUAB Pharma a.s.
Vltaysk 53
Roztoky 25263
Czech Republic

Reference: FEI 3003002370

Dear Mr. Mengler:

We have completed our review of the Establishment Inspection Report (EIR) for the inspection conducted at your active pharmaceutical ingredient manufacturing facility in Roztoky, Czech Republic by Investigator Lucas B. Leake and Interdisciplinary Scientist Paul A. Bonneau during the period of November 03-05, 2015. A Form FDA-483, Inspectional Observations was issued at the conclusion of the inspection.

We have also reviewed your company's responses dated November 25, 2015 and February 23, 2016 with supportive documentation. Based on the profile class covered during the inspection, we are classifying your facility as acceptable. This letter is not intended as an endorsement or certification of the facility. It remains your responsibility to assure continued compliance with current good manufacturing practices (CGMP).

Please be advised that all manufacturers must register annually as required by 21 C.F.R. § 207.40. Information on how to register is available at http://www.fda.gov/cder/drls/registration_listing.htm.

Additionally, we enclose a copy of the establishment inspection report (EIR). Releasing this EIR to you is part of FDA's effort to make its regulatory process and activities more transparent to the regulated industry. It is being provided to you for information purposes only and may reflect some redactions made by the Agency in accordance with the Freedom of Information Act and 21 C.F.R. Part 20. Copies provided to other requestors may have additional redactions of trade secret and confidential commercial information.

If you have any questions regarding this letter, you may contact me at the above address or number.


Sincerely,

/S/

David S. Jones
Acting Team Lead
Division of Drug Quality II


Enclosure: EIR