- Cheng Fong Chemical Co., Ltd.
- Issuing Office:
- Center for Drug Evaluation and Research
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
Warning Letter 320-16-33
Return Receipt Requested
September 15, 2016
Mr. Hung Chih Wu
Cheng Fong Chemical Co. Ltd.
No. 19, Gong 4th Road
Taoyuan City 337, Taiwan
Dear Mr. Wu:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cheng Fong Chemical Co. Ltd., at No. 19, Gong 4th Road, Dayuan District, Taoyuan City from April 18 to 22, 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).
We reviewed your May 13, 2016, response in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigator observed specific deviations including, but not limited to, the following.
1. Failure to have an adequate maintenance procedure to prevent contamination or carry-over of a material that would alter the quality of the API.
Our investigator observed corrosion, pitting, dirt, and leaks, on and around your drug manufacturing equipment.
For example, we observed pitting on the product contact surface of equipment (b)(4)-201, (b)(4)-202, and (b)(4)-203 used to process (b)(4) API.
In your response, you provide updated equipment line clearance and maintenance procedures, photos of cleaned or repaired equipment, and a list of batches potentially impacted by the poorly maintained equipment.
2. Failure to adequately conduct investigations and extend the investigations to other batches that may have been associated with the failure or deviation.
You did not adequately investigate customer complaints for black or (b)(4) foreign particles in your finished (b)(4).
For example, you received particulate complaints for (b)(4) batch (b)(4), but rather than evaluating reserve samples for that batch, you evaluated a different batch of (b)(4) API (batch number (b)(4)). You found that batch (b)(4) contained foreign matter, yet you did not determine the identity of the foreign particulates in either batch or implement adequate corrective action.
Your response acknowledged that the foreign particle complaints are likely due to the poor condition of manufacturing equipment.
Your investigations into poor equipment maintenance and foreign particles are inadequate as you did not identify the foreign matter in your API, or sufficiently extend the investigations to other lots that may have been contaminated. Regarding the latter, reserve samples of all potentially-affected batches were not examined for presence of foreign matter.
3. Failure to properly maintain buildings used in the manufacture of API in a clean condition.
For example, our investigator observed filth, insects, wet layers of (b)(4) unidentified material on the floors, and foul odors in the cold rooms used to store raw materials and intermediates used in the manufacture of your finished API. Firm officials noted that the rooms had never been cleaned.
We acknowledge your corrective actions, including cleaning, and adding the cold rooms to your pest control program.
In your response to this letter, provide the following:
- An updated and comprehensive investigation into your customer complaints
- A corrective action and preventive action (CAPA) plan that includes identification of the foreign particles, your assessment of root cause, the impact on other potentially affected batches, and actions taken to prevent recurrence
- Updated and comprehensive assessment of the state of maintenance of all equipment that can be used in the manufacture of APIs for US supply
- A comprehensive assessment of the adequacy of your maintenance program
- An evaluation of the adequacy of your cleaning procedures
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 from CGMP.
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at email@example.com, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.
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 refusing admission of articles manufactured at Cheng Fong Chemical Co. Ltd., No. 19, Gong 4th Road, Taoyuan City 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.
Marisa Heayn, Consumer Safety Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
Please identify your response with FEI 1000174711.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research