DPT Laboratories Has Fixed Violations
Lakewood Drug maker DPT Has Fixed Violations [Asbury Park Press, N.J.]
From Asbury Park Press (NJ) (March 20, 2013)
March 19--A Lakewood drug maker has fixed the violations that caused federal regulators to warn it to improve its manufacturing standards, the U.S. Food and Drug Administration said.
DPT Laboratories, in releasing the FDA’s letter on Tuesday, said it would continue to invest what it called significant resources in its compliance.
"We are pleased to have this issue behind us and appreciate the confidence our new and existing customers demonstrated in us during this time," Eugene Ciolfi, DPT’s vice president and general manager, said in a statement.
DPT is a contract pharmaceutical manufacturer based in San Antonio, Texas. It operates a 175,000-square-foot plant in Lakewood, where it makes sterile and specialty products and employs 230. The company is owned by Renaissance Acquisition Holdings, a Lake Forest, Ill.-based private-equity company.
DPT has said it spent more than $40 million to expand and upgrade the Lakewood facility since 2010.
The FDA in September released a warning letter, saying the company didn’t properly investigate what caused the sterility failure of six lots of Santyl Ointment, a prescription drug used to heal wounds, that were made at the Lakewood plant dating to December 2010.
Regulators also said in the warning letter that they weren’t confident that the initial steps DPT took to ensure the product would be made safely were sufficient.
The Lakewood plant continued to operate while it addressed the FDA’s issues. The FDA in a letter dated Feb. 19 said it completed its evaluation of DPT’s corrective actions and found the company had addressed its concerns.
Michael L. Diamond; 732-643-4038; firstname.lastname@example.org
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Posted: March 2013