The QMN Weekly Bulletin

FDA Slams Foreign API Makers Over Data Deficiencies, Falsification

July 8, 2016

Four foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies.

A warning letter to Mumbai, India-based Megafine Pharma accuses the API maker of significant deviations from GMP that render products from one of their facilities in Nashik adulterated. The letter stems from a May 2015 inspection that uncovered multiple instances of records falsification, which led the agency to deem the company’s quality system deficient, according to the letter.

The letter notes that a company analyst admitted to falsifying test data for a stability batch in August 2012, but Megafine failed to determine the possible extent of the data falsification. This inaccurate information was submitted to the agency as part of the company’s drug master file.

In another case, multiple analysts testing drug purity deleted unknown peak readings without justification, apparently to prevent the batches from falling outside of specifications.

Moreover, the site failed to adequately investigate batches failing to meet specifications or quality standards. For example, the firm’s quality unit released a batch for distribution despite failing to meet an impurity specification.

Corden Pharma Letter

Sermoneta, Italy-based Corden Pharma Latina S.p.A. was slammed for several finished product violations following a May 2015 inspection.

The letter contends that Corden’s facilities are not appropriately constructed to enable proper cleaning and maintenance.

For example, the inspector noticed the presence of “black grime and filth” on floor tiles in a sterile manufacturing area. According to the letter, cracked and inadequately repaired floor tiles produced gaps holding the filth.

The firm also failed to clean, maintain and sanitize equipment at proper intervals to prevent contamination, the letter states.

Specifically, the facility’s cleaning procedure involves spraying water throughout the aseptic area, which collects underneath the aseptic filling machine, the FDA says. According to the agency, this is a potential source of microbiological contamination.

Corden was further accused of not establishing laboratory controls that are science-based. The site, according to the letter, relied on sampling that does not provide meaningful results for some analyses.

BBT Biotech Letter

An FDA inspection of BBT Biotech’s facility in Baesweiler, Germany, concluded that the company failed to implement proper controls over its computer systems. A warning letter says that all of the firm’s employees had administrator privileges to one of the systems and shared a common user name, preventing investigators from attributing non-compliant conduct to a single individual.

The company also copied raw data to a CD from a hard drive and then deleted the data to free space on the hard drive without assurance that the data files were copied to the CD before they were permanently deleted, the letter asserts.

BBT also was accused of failing to follow a documented stability testing program to monitor the characteristics of its APIs. Specifically, the firm did not include stability data to support expiration dates of several API batches shipped to the U.S., the letter states.

Moreover, the API maker was swatted for failing to set up a change management system to evaluate product revisions that could impact production and control of its ingredients, as well as the inadequate investigation of out-of-specification results.

Tai Heng Letter

The FDA also slammed Chinese API manufacturer Tai Heng Industry for data destruction at its facility in Shanghai.

An investigator found during an inspection that the firm failed to complete batch production and control records immediately after activities were performed, according to the letter. The agency says that operators used mock data sheets to record critical manufacturing data, which it later replaced with backdated records that it presented as the official records.

The inspection between May 4 and May 11, 2015, uncovered other issues, including the firm’s lack of basic controls to prevent manipulation of electronically stored data and paper records. The investigator also faulted the company for its reliance on incomplete records to evaluate the quality of drug products, according to the letter.

For example, the company routinely re-tested samples without justification and deleted analytical data, the letter states. Several analysts also were accused of systemically manipulating data across the facility on multiple pieces of testing equipment.

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