Nobilus Poland plant gets import ban after FDA warning

Even as Congress considers giving the oft-criticized FDA inspection program more money, warning letters posted this week on the FDA website give some indication of the breadth of the agency's responsibilities and just why it is in such need. They include warning letters to an API plant in Poland, a drug manufacturing plant in Mexico and a medical device manufacturer in China. 

The API plant of Nobilus in Kutno, Poland, flunked inspection in September, resulting in all drugs produced there being banned from the U.S. with the continuation of an import alert.

Without specifying what it was, inspectors were most concerned with the way the facility was treating a specific ingredient. They say the company does not adequately separate it from other ingredients, "from receipt, through storage and processing," to protect against cross-contamination.  

The reaction process, the FDA says, occurs "in a non-dedicated facility; the operations occur in non-dedicated equipment in a non-dedicated room."

In Mexico, inspectors found that the Laboratorios Jaloma plant in Guadalajara doesn't have the equipment necessary to test batches to ensure that they contain prescribed ingredient strength, and it isn't using a contractor to test. There are no procedures in place to guarantee "drug products produced have the identity, strength, quality and purity they purport or are represented to possess." And there is no data to validate expiration dates, the FDA claims.

Finally, the inspection of a Shanghai Apolo Medical Technology plant found, among other issues, that the company didn't have procedures or documentation that the Pulsed Light (IPL) Systems used in dermatology treatments met specifications. The company also lacks procedures for investigating and handling complaints. 

The FDA has a large backlog of inspections and hopes to catch up by collecting nearly $300 million a year in user fees from generic drugmakers, Pharmalot points out. That includes $50 million the first year from a special one-time backlog fee on abbreviated new drug applications pending on Oct. 1, 2012.

Under the proposed fees being considered by Congress, InPharma Technologist explains, non-U.S. plants will pay between $15,000 and $30,000 more than U.S. facilities to cover the additional costs associated with foreign inspections.

- see the warning letter to Nobilus
- check out the Laboratorios Jaloma letter
- here's the Shanghai Apolo letter
- get more from Pharmalot's observations
- read InPharma's story

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