Not following through to fix problems noted by FDA inspectors is sure to land manufacturers in trouble with the FDA, and contract manufacturer Shamrock Medical Solutions has received a warning letter that proves it.
The Lewis Center, OH, CMO promised after an inspection last year that it would keep technicians from accessing the company's master labeling program after "four separate Incident Reports concerning mislabeled products," but then failed to follow through, the warning letter says. As a result, more mislabeled drugs were released for distribution, including thyroid medication Levothyroxine, blood pressure medication Diltiazem and heartburn medication Metoclopramide.
The FDA says the release of mislabeled drugs was also an indication Shamrock had not adhered to its written procedures that all lots must be reviewed by the quality control unit before release.
Shamrock also was criticized for its handling of opioids. The letter says the company has no written procedures for the manual repackaging of liquid drugs into oral syringes or fluid dose cups. Its says Shamrock has received complaints from customers that some products, including oxycodone hydrochloride and 7 lots of morphine sulfate oral solution, contained air bubbles and had low fill volumes. The company also is not checking the weights of all of the drugs it repackages, the FDA says.
Inadequate handling of data and computer systems has come up in other inspections of late. Gulf Pharmaceutical was criticized in a warning letter in February because it had insufficient computer storage space to keep all of the assay test results.
The company did not respond to a request for comment.
- read the warning letter
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