APIs WERE MISBRANDED
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China) was inspected from October 21-24, 2013 at their active pharmaceutical ingredient manufacturing facility. Deviations from CGMP were noted in the manufacture of the API.
- “Failure to implement an effective system of managing quality and failure to transfer all quality or regulatory information received from the API manufacturer to your customers.
Your trading company, hereafter referred to as Zonebanner, purchased APIs from an outside supplier and relabeled them without the oversight of a quality unit. The information from the original certificate of analysis, generated by the actual manufacturer, was transferred to a new certificate of analysis on Zhejiang Jiuzhou Pharmaceutical Co. letterhead with no information about the original manufacturer or analytical laboratory performing the analyses. In addition, a new label identifying Zhejiang Jiuzhou Pharmaceutical Co. as the manufacturer was added to drums. In doing so, your firm essentially obscured the supply chain of these APIs.
Zonebanner had no quality system in place for the relabeling operations. In addition, we note that in at least one instance of a lot of gabapentin shipped to the U.S., the retest date from the original manufacturer’s certificate of analysis (November 2013) was changed to an expiration date listed as eleven months later (October 2014) on the new certificate of analysis…
In response to this letter, provide details of the proposed quality system to be implemented at Zonebanner. Describe procedures and provide examples that demonstrate that traceability is maintained for currently distributed APIs and that information sent to customers includes an accurate representation of the manufacturer and analytical testing laboratory. In addition, provide your rationale for the expiry extension of the gabapentin lot described above. If this or other similar extensions were unsupported, then describe your intended actions for the lot(s) in question.”
Unfortunately, this is not the first of these kinds of issues arising within China. Transferring of information to a new certificate of analysis on Zhejiang Jiuzhou Pharmaceutical Co. letterhead with no information about the original manufacturer or analytical laboratory performing the analyses obscures the supply chain of APIs. In addition, changing the original manufacturer’s certificate of analysis to an expiration date listed as eleven months later on a new certificate of analysis.
“In addition to violating CGMP, your firm shipped a misbranded active pharmaceutical ingredient to the U.S. As described above, according to our inspection, your firm prepared a certificate of analysis (COA) for gabapentin on your firm’s letterhead, indicating that the product was manufactured by your firm, Zhejiang Jiuzhou Pharmaceutical Co., Ltd, when in fact it was not. The gabapentin was manufactured by (b)(4). In addition, the expiration date on your firm’s COA is not one supported by the COA from the original manufacturer, (b)(4).
Moreover, your firm relabeled gabapentin and included on the label an official stamp that identifies your firm, Zhejiang Jiuzhou Pharmaceutical Co., Ltd, as the manufacturer of the product, rather than the actual manufacturer, (b)(4). Based on our findings, the active pharmaceutical ingredient, gabapentin, is misbranded within the meaning of Section 502(a) of the Act [21 U.S.C. 352(a)] in that its labeling is false or misleading in any particular. See also 21 CFR 201.1(h)(2).”
Including on the label an official stamp that identifies this firm as the manufacturer of the product, rather than the actual manufacturer constitutes misbranding within the meaning of the labeling as false or misleading.