WARNING LETTER

Skylark CMC Pvt. Ltd. MARCS-CMS 567229 — December 03, 2018

Reference #:: 320-19-06

Recipient:: Recipient Name

Tushar Patel; Recipient Title

Director; Skylark CMC Pvt. Ltd.; Skylark CMC Pvt. Ltd.; Near Electric Sub Station
Odhav Road
Ahmedabad, Gujarat 382415
India

Issuing Office:: Center for Drug Evaluation and Research; United States

Dear Mr. Patel:

On June 25, 2018, the U.S. Food and Drug Administration (FDA) arrived at your drug manufacturing facility, Skylark CMC Pvt. Ltd. near Electric Sub Station, Odhav Road, Ahmedabad, Gujarat, to conduct an inspection.

Our investigator documented that your firm limited and/or refused an FDA inspection. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration and Innovation Act (FDASIA), section 707, 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection.

Your firm limited the inspection and/or refused to permit the FDA inspection as follows:

1. Barring access to areas

During the inspection, your firm limited the investigator’s access to the manufacturing area. Your employee stated that your firm was currently manufacturing and packaging drug products; however, you prevented the investigator from entering the manufacturing area.

2. Refusal to provide copies of documents

During the inspection, FDA requested records, including a list of drug products you manufacture, as well as some of your facility’s shipping records. Your firm limited the inspection by refusing to provide copies of these records to FDA.

Access to Information During Inspection

When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf.

Additional Observations Regarding Your Facility

FDA conducted an unannounced inspection of your facility because research indicated it has the same physical address as Vikshara Trading & Investments Ltd. (FEI 3004982352), a firm that is currently on FDA Import Alert 99-32, “Detention Without Physical Examination of Products from Firms Refusing FDA Foreign Establishment Inspection.” This import alert can be found on the FDA public website at https://www.accessdata.fda.gov/cms_ia/importalert_521.html.

Conclusion

Violations cited in this letter are not intended to be an all-inclusive list. You are responsible for investigating and determining the causes, for preventing their recurrence, and for preventing the occurrence of other violations.

FDA placed your firm on Import Alert 99-32 on November 8, 2018.

Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Skylark CMC Pvt. Ltd. near Electric Sub Station, Odhav Road, Ahmedabad, Gujarat, into the United States are subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).

After you receive this letter, respond to this office in writing within 15 working days.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:

Lynnsey Renn, Ph.D.
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA

Please identify your response with FEI 3003658163.

Sincerely,
/S/
/Francis Godwin/
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

cc:  Sumit D Rajani
       Umendra Exports Pvt. Ltd.
       1102 Devika Tower
       6 Nehru Place
       New Delhi 110019
       INDIA