FDA Issues Warning Letter to API Manufacturer

FDA issued a warning letter on May 27, 2015 to VUAB Pharma, a manufacturer of APIs and solid-dosage forms located in the Czech Republic, for cGMP deviations including the distribution of contaminated APIs and inadequate data control. According to the warning letter, the company had received multiple customer complaints that samples of API received tested positive for microbial contamination.

One customer’s on-site audit of the company in May 2014 found inadequate test methods for detecting Clostridium sphenoides. FDA states in the warning letter that the company did not identify the source of contamination or implement the necessary corrective and preventive actions (CAPA) to prevent future contamination. FDA further stated that the contamination was of further concern because the company manufactures the API in question on common equipment using common materials and personnel, possibly affecting multiple customers.

Another customer complaint involved Bacillus spp. contamination of API. FDA cited the company for not investigating other potentially affected batches and states,  “deficient sampling procedures compromised your firm’s ability to detect the contamination your customer found. Your firm sampled (b)(4) per batch and had no statistical justification that this sample was representative of the entire batch.”

FDA also stated that the company failed to protect data from unauthorized changes, access, or omissions. According to the agency, the company failed to retain complete raw data from quality testing and did not put “proper controls in place to prevent unauthorized manipulation of your laboratory’s raw electronic data. Our inspection revealed your HPLC system did not have access controls to prevent alteration or deletion of data. Your HPLC software lacked an audit trail recording any changes to the data, including: previous entries, who made changes, and when changes were made. During the inspection, we also noted that all laboratory employees shared a common log-in and password to access the system.”

Source: FDA.gov