Changes to manufacturing processes not validated at Lex

Validation Times, Feb, 2005 by Evelyn Heitman

FDA investigator Jennifer Medendez visiting Lex,

Additionally, Lex had never established the reliability Inc., Medley, FL, a manufacturer of various OTC and Rx drug products, found that the firm did not validate changes to the manufacturing processes, including scale-up of batches. of the supplier's analyses through proper validation of the supplier's test results at appropriate intervals. According to the letter, the firm also had not conducted at least one specific identity test to verify the identity of the active drug ingredients used to manufacture drug products.

According to the Dec. 7, 2004, warning letter, the quality control unit had not approved the SOPs, and a review of complaints involving the possible failure of a drug product had not been performed per those procedures.

Furthermore, there was no documentation that the batch production records had been reviewed and approved by the quality control unit, and employees of Lex had never received any type of current GMP training.

In addition, the company failed to conduct microbial analysis and/or preservative assays on finished drug products as a criteria for release; failed to determine the identity and strength of active ingredients for several products; and there was a lack of data to support the firm's two and three-year expiration date(s) for its drug products.

The warning letter also noted that the statement of the actual yield was not calculated and recorded in the batch production record. Also, the batch production record did not include in-process results (i.e., weight checks) for each batch of drug product produced; and there was no written testing program designed to assess the stability characteristics for several drug products.

The agency further cited Lex for failing to establish and follow appropriate written procedures to prevent microbiological contamination. For example, operating procedures (i.e., meaningful microbial action limits and a corrective action plan when action limits were exceeded) for the water purification system had never been established.

Calls to the company were not returned before deadline. Doc. 13355W