WARNING LETTER
Lumis Global Pharmaceuticals Co. Ltd. MARCS-CMS 516043 —
- Recipient:
- Lumis Global Pharmaceuticals Co. Ltd.
United States
- Issuing Office:
- Center for Drug Evaluation and Research
United States
| |
10903 New Hampshire Avenue Silver Spring, MD 20993 |
Via UPS Warning Letter 320-17-27
Return Receipt Requested
March 2, 2017
Ms. Jocelyn (Jun) Ning
Owner
Lumis Global Pharmaceuticals Co. Ltd.
Unit 305 Huishang Mansion Building A
2 Wudayuan Road Donghu New Technology Development Zone
Wuhan, Hubei, 430073
China
Dear Ms. Ning:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lumis Global Pharmaceuticals Co. Ltd. at Unit 305 Huishang Mansion Building A, 2 Wudayuan Road Donghu New Technology Development Zone, Wuhan, from September 26 to 28, 2016.
This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
In addition, your gabapentin API is misbranded under sections 502(a) and 502(b)(1) of the FD&C Act, 21 U.S.C. 352(a) and 352(b)(1).
We reviewed your November 9, 2016, response in detail. We note your response addressed some FDA observations, but did not address the issues noted below.
During our inspection, our investigator observed specific deviations including, but not limited to, the following.
CGMP Deviations
1. Failure to transfer all quality or regulatory information received from the API manufacturer to your customers.
You omitted the name and address of the original API manufacturers on the certificates of analysis (COA) you issued to your customers, and did not include copies of the original batch certificate.
For multiple API, you generated COA by copying and pasting analytical results from the original API manufacturers, replacing the manufacturers’ information with your letterhead, then issuing these COA to your customers. You omitted critical information, including the original manufacturers’ names and addresses and the names, addresses, and telephone numbers of laboratories that performed the testing.
Customers and regulators rely on COA for information about the quality and sourcing of drugs and their components. Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk.
2. Failure to control the API repackaging, relabeling, and holding operations in order to avoid mix ups and loss of API identity.
Our FDA investigator documented unlabeled material in your “released for shipping” area. You told the investigator that this material was not to be released to customers, but was in fact intended for destruction.
To avoid mix-ups between materials that can and cannot be released, or between different API, you must repackage, relabel, and hold API under appropriate CGMP controls.
3. Failure of your quality unit to exercise its responsibility to ensure the API relabeled at your facility are in compliance with CGMP.
Your relabeling operation was not documented adequately. You did not document the time and date of relabeling operations, nor the employee who conducted relabeling operations for API you distributed. You did not sign and date records at the same time the activites were performed.
Misbranding Violations
The gabapentin API labels bear the statement “Manufactured under cGMP conditions by: Lumis Global Pharmaceuticals Co., Ltd.” This statement is misleading because it indicates that the manufacturer of the API is Lumis Global Pharmaceuticals Co., Ltd. instead of (b)(4). Therefore, the gabapentin APIs is misbranded under section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that the API labeling is misleading.
In addition, section 502(b)(1) of the FD&C Act requires a drug to contain the name and place of business of the manufacturer, packer, or distributor of the drug. The label of Lumis’ API product is misbranded under section 502(b)(1) because it misidentifies Lumis, which is a distributor or packer, as the manufacturer. As evidenced by the certificates of analysis, (b)(4) is the manufacturer of the gabapentin API, not Lumis Global Pharmaceuticals Co. Ltd.
Shipping drugs from a manufacturer on FDA Import Alert 66-66
(b)(4), one of your suppliers, has been on Import Alert 66-66 since (b)(4), specifically for their (b)(4) USP API. However, you shipped (b)(4) USP API manufactured by this firm to the United States in February 2015 and declared that you were the manufacturer on importation documents.
CGMP consultant recommended
Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations and assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
Additional API CGMP guidance
FDA considers the expectations outlined in ICH Q7 in determining whether API are manufactured in conformance with CGMP. See FDA’s guidance document, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, for guidance regarding CGMP for the manufacture of API, at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073497.pdf.
Your response
In response to this letter:
- Provide written procedures for transferring quality and regulatory information, including the information you send to your customers.
- Provide a plan to establish, document, and implement an effective system for managing quality. Include written procedures for CGMP-related activities and the roles of personnel responsible for oversight.
Conclusion
Deviations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these deviations, for determining the causes, for preventing their recurrence, and for preventing other deviations.
FDA placed your firm on Import Alert 66-40 on February 15, 2017.
Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these deviations may also result in FDA continuing to refuse admission of articles manufactured at Lumis Global Pharmaceuticals Co. Ltd. at Unit 305 Huishang Mansion Building A, 2 Wudayuan Road Donghu New Technology Development Zone, Wuhan, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your deviations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
Runa Musib, Ph.D.
Interdisciplinary Scientist
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 3010280514.
Sincerely,
/S/
Thomas J. Cosgrove
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research