McNeil Consumer Healthcare — FDA 483 Findings

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strenght, quality, and purity they purport or are represented to possess Specifically, Lack of process valida tio n f or the manufacture of Infant's Dye-Fr ee tyl enol susp ension dro ps, cherry, fo rmula REDACTED (b) (4) 80 ml/0.8 mL.

The persons double-cbecldng the cleaning and maintenance a~e not dating and signing or initialing the equipment cleaning and use log, Specifically, No second signature verifying that maintenance was completed.

samples taken of in-process materials for determination of conformance to specifications are not representative.

written specifications for laboratory controls do not include a description of the sampling procedures used.

Strict control is not exercised over labeling issued for use in drug product labeling operations.

GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.

each lo t of compone nts was not appropria tly identifie d as to its s tatus in term s of being quarantined, approved or rejected.

Laboratory records do not include complete records of the periodic calibration of laboratory instruments, gauges, and recording devices.

control procedures faol to include adequacy of mixing to assure uniformity and homogeneity.

Written production and process control procedures are not followed in the execution ofproduction and process control functions.

Components are not microscopically examined when appropriate.

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

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been ah'eady distributed, Specifically, 1.

There is no written testing program designed to assess the stability characteristics ofdrug products.

Each container of component dispensed to manufacturing is not examined by a second person to assure that the weight or measure is correct as stated in the batch records.

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Records are not kept for the maintenance and inspection of equipment.

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

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.