CHASE LABS GMP VIOLATIONS RESULT IN FDA WARNING LETTER

Executive Summary

CHASE LABS GMP VIOLATIONS RESULT IN FDA WARNING LETTER dated Nov. 4 that cites "critical and significant deviations from Current Good Manufacturing Practices" uncovered during an inspection of Chase Laboratories' Newark, N.J. facilities on Sept. 1, FDA said. The letter lists seven observations of cGMP deviations relating to equipment qualification, unvalidated procedures, lack of product failure documentation, absence of written procedures and lack of quality assurance procedures. In the warning letter, FDA cited Chase Labs for the "use of unvalidated dissolution procedure for nifedipine capsules." After FDA's last inspection of the company's Newark facility in September 1992, Chase initiated a Class II recall of an estimated 3 mil. nifedipine softgel 10 mg capsules because of a "lack of assurance to meet compendial dissolution requirements" ("The Pink Sheet" Nov. 23, 1992, T&G-10). The recall of the generic calcium channel blocker, the company's last to date, was completed in April 1993. Other deficiencies cited by the agency include: "failure to completely and adequately qualify all manufacturing and laboratory equipment"; "failure to completely or adequately validate all dosage form drug products, including the lack of validation protocols and/or reports for many drug products"; "failure to completely and adequately conduct and document product failure investigations"; "failure to have written procedures for GMP training for manufacturing and laboratory personnel"; "failure to completely and adequately conduct annual production reviews"; and "failure to audit the chemistry and microbiology laboratories to assure procedures are in date, approved and adequately conducted." The letter adds that "because the type of deviations noted affect all drug products manufactured by your firm, until corrections are verified, federal agencies will be informed that FDA recommends against the award of contracts." Chase Laboratories said Nov. 17 that "broadly, the issues in the warning letter have been addressed." The company has drafted and is reviewing a response, which it expects to have to FDA before the Nov. 19 standard 15-day response deadline.