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Manufacture Standards & Regulation, Small Molecules

Problem Plants

We’re only into the first quarter of 2016, but some companies are already having a bad year. January and February have been packed with reports of unsatisfactory FDA and EMA regulatory inspections of facilities outside of the US and Europe.

A Chinese facility was described by the EMA as being in a “devastated state” (1) after an inspection late last year. The EMA found “huge layers of dust and product” indicating that “no cleaning was applied to either the facility or the equipment, leading to an extreme risk of cross-contamination.” During the evaluation for metronidazole production, inspectors noted two dozen violations of EU standards, spanning the entire spectrum of manufacturing. The EMA have recommended that authorities recall any Hubei Hongyuan products and that the company be banned from shipping any new product.

India’s Wockhardt felt the burn as their new sterile injectable plant failed to get approval from the FDA. A Form 483 was issued, with nine observations, during an inspection at a new facility in Shendra, Aurangabad (2). The criticism follows a series of setbacks for Wockhardt after the FDA banned imports into the US from two of its key drug plants over the last three years due to quality concerns.

The FDA also visited China, issuing a warning letter to Chan Yat Hing’s Medicine Factory following a visit to its Hong Kong facility. The FDA found that the plant was not meeting any of the usual protocols for producing drugs for the US markets (3). The letter cited failures to test finished batches, ensure compound identity, and establish written procedures, among other violations. The FDA noted that the facility “released multiple batches of drug products for distribution, despite these and other violations.”

And the crackdown is set to continue. Pharma companies that fail to meet standards could face further inspections from the FDA, which has announced that struggling plants will face more frequent inspections as part of a shift in the way it oversees drug quality. A report from the PwC Healthcare Institute states “Inspections will become more uniform, though potentially more difficult as specialized inspectors, already familiar with the product and armed in advance with data, can hone in on problems more easily,” (4). JS

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  1. EudraGMDP Report (January, 2016). Reports available at
  2. BSE India Report, (January, 2016). Reports available at
  3. FDA Warning Letter, “Chan Yat Hing Medicine Factory 12/15/15,” (December, 2015).
  4. PwC Healthcare Institute, “Major shift ahead in how FDA regulates drug quality,” (February, 2010).
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