All American Pharmaceutical & Natural Foods was also found to have unmarked barrels and unweighed raw materials in its storage facilities and given 15 days to notify the FDA of its plans to bring its activities into line with the Good Manufacturing Practice regulations.
Master manufacturing record
The FDA 483 inspection report noted that the firm failed to follow a, “written master manufacturing record for each unique formulation of a dietary supplement that you manufacture, and for each batch size”.
The company provided material bills for some its dietary supplement but the FDA said they were not detailed enough as they didn’t specify, “the manufacturing process, nor establish controls and procedures to ensure that the specifications are met”.
Batch production record (BPR)
The FDA found fault with BPRs that did not reconcile, “discrepancies between issuance and use of labels”. Inspectors said there was no labelling space for such reconciliation to occur and none had been recorded anyway.
“This dietary supplement requires such reconciliation because examination for correct labels is not performed by electronic or electromechanical equipment,” FDA wrote.
It continued: “The nonconformance report that you indicate was added to explain discrepancies between the number of labels used and the number of completed bottles does not address discrepancies between the issuance and use of labels. Your response also states that you have added a label reconciliation procedure; however, it does not address the missing information required to be on your batch records nor does it include written instructions for reconciliation.”
The company also failed to dates and times for maintaining, cleaning and sanitizing its equipment and processing lines or cross-reference to records such as equipment logs where the information is retained. It also failed to identify equipment and processing lines used in certain batches; others failed to identify blenders and capsule presses.
The company said it had subsequently brought this information up to date.
Packing labels that were damaged were not kept for reconciliation, the FDA wrote, and no contol measures were in place to ensure correct labels were used.
“Furthermore, our investigators observed that the quantity of roll stock pressure sensitive labels returned to the label room was inaccurate because the number of labels issued only reflected the number required in the batch ticket.”
It added: “We note that our investigator observed several instances in which your firm failed to take all the necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements including segregating and identifying all containers for a specific batch of dietary supplements to identify their contents and, when necessary, the phase of manufacturing.”