Meridian Medical Technologies, Inc. a Pfizer Company — FDA 483 Findings

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product.

Procedures for design validation have not been adequately established.

Procedures for design verification have not been adequately established.

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.

Procedures describing the handling of all written and oral complaints regarding a drug product are not established, written and followed.

Procedures for design output have not been adequately established.

DEPARMENTOFHEALTHANDIREKANSERVICES FOODANDDROGADYMOSTRANON DISTRICT ACORESS AND RCM MAILER DA MS) OF INWECT1ON 8050 Marshall Drive, Suite 205 2/20/2017-3/24/2017* PEI MIIIBER Lenexa, KS 66214 1950222 (913)495-5100 Fax: (913)495-5115 Iola MO ME OFOCIVIDUAL TO IfsH011REFORT ISSUED Thomas E.

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been adequately established.

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.

The quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging material and drug products.