Ohm Laboratories, Inc. — FDA 483 Findings

You fuiled to always maintain a backup file of data entered in the computer or related system as well as failed to have a procedure in place for backup operation to assure that the data is exact, complete, and secure from alteration, erasure or loss through keeping hard copy or alternate systems.

TYPE ESTABUSHMENT INSPECTED Rx Drug Manufacturer Complete records shall be maintained for any testing and standardization of laboratory reference standards, reagents, and standard solntions.

An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.

Samples of representative units were not collected and visually examined for correct labeling at the completion of finishing operations.

An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a fililure of one or more distributed batches ofa drug to meet the specifications established for it in the application.

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and =,=",,~~~1f!lJr:~or~~ 9~g}!l~r.r~~0!~~em~titJI~'!0nlr bxal1t1l0Iiz<;£lp~s~L.

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

Procedures describing the calibration ofinstruments and apparatus are deficiently written or followed.

Written procedures are not followed for the sampling and testing ofcomponents.

TYPE ESTABLISHMENT INSPECTED Rx Drug Manufacturer The written stability program for drug prodncts does not describe the storage conditions for samples retained for testing.

The master production and control records are deficient in that they do not include complete manufactnring, control, instructions, special notations, and precautions.

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

Laboratory records do not iIlclude the initials or signatnre of a second person showillg that the origillal records have been reviewed for accuracy, completeness and compliance with established standards.

An annual report did not include information about the quantity of the drug product distributed under the approved application, including that distributed to distributors.

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Failure to reject any lot of components and drug product containers that did not meet the appropriate written specifications for identity, strength, quality, and purity.