Enforcing FDA Labeling Policies

As a cGMP and DEA registered facility, DYNALABS takes proper sample labeling very seriously.  DYNALABS has always had a labeling policy in place, and beginning in May, 2016, we reinforced to all customers through the SLA/MSA agreements the importance of this policy.  From a compliance and quality perspective, we need to ensure the accuracy of the labels and will place on hold mislabeled or illegibly labeled samples.

The following is explicitly displayed during the sample submission process.

• The best corrective action for a mislabeled sample is to send in physical self-adhesive labels for DYNALABS to affix to the samples along with a copy of the email communication about the label error that has been signed by someone at your facility.
• For your convenience DYNALABS can correct the labels for you or print and affix a corrected version for a nominal fee.
• All mislabeled samples are exempt from any Service Level Agreement turnaround times and receipt will be delayed until the issue is resolved and, if needed, additional supporting documentation is provided.

Dynalabs wants to ensure smooth flow of all samples and as such mistakes happen and can work behind the scenes to remedy the issue.

1. The first time, or rare occurrence, of mislabeled samples DYNALABS will resolve the labeling issue with you at no additional charge as long as the appropriate information can be provided.
   • The amount of work to label the samples must be within reason
   • The customer must accept a phone call explaining the issue and the correct labeling procedure.
   • The customer will be sent a follow up email summarizing the retraining
2. The second time a sample is mislabeled DYNALABS will resolve the labeling issue at no additional charge as long as the appropriate information can be provided.
   • The amount of work to label the samples must be within reason
   • The customer must accept a phone call explaining the issue and the correct labeling procedure.  The customer will be informed that continued violations will result in additional charges and/or materials being returned.
3. The customer will be sent a follow-up email summarizing the retraining;
   • Continued receipt of mislabeled samples will result in additional charges or returned materials
   • DYNALABS will resolve the labeling issue with you for an additional charge as long as the appropriate information can be provided.  The fee starts at $45.00 and is incrementally increased based on level of effort
   • If the customer cannot be contacted after three attempts the materials will be sent back and the shipping will be charge or billed to the customer.