Impax Resolves Mfg IssuesBy
Impax Laboratories, Inc., a specialty pharmaceutical company, has received written notice from the US Food and Drug Administration (FDA) verifying that the company has successfully addressed all items raised by the FDA in the May 2011 Warning Letter relating to its Hayward, California manufacturing facility.
The FDA notice follows a re-inspection in 2015 by the FDA of the Hayward facility. Receipt of the FDA notice means that the remediation activities at the company’s Hayward facility and its quality management and compliance systems of the facility are deemed to be acceptable.
The company said that it plans to increased spending to prepare for new product launches from the facility. “With the resolution of the Warning Letter, we are excited about the potential for approvals and launches of new products from this facility. While we cannot predict the timing of approvals, we are planning to accelerate certain spending initiatives during the remainder of 2015 in order to prepare for these potential events,” said Fred Wilkinson, president and chief executive officer of Impax, in a company statement.
Source: Impax Laboratories