In a recent 483, a relabeler was cited for failing to have lot numbers and expiration dates on its customer invoices. This 483 stresses the broader importance of traceability systems in the case of a recall. It can be inferred that this particular company lacked any other similar traceability systems and the customer invoices were a last line of defense.
The observation is unique for specifically referencing the firm’s invoice, however the intention is clear. FDA expects all regulated entities to maintain a tracking system that can be utilized to cross-reference products through lot numbers and expiration dates.
The observation reads as follows:
Specifically, your firm lacks a distribution system in place to determine the distribution of each lot of drug product to facilitate a recall if necessary. The firm’s invoice does not contain a lot number or an expiration date. Furthermore, there is no written procedure on how a recall will be conducted if a contract manufacturer initiates a recall. In the event a recall is initiated, your firm failed to guarantee how clients will be identified.
According to 21 CFR 211.150
Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:
(a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.
(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.
In accordance with this CFR citation and highlighted in the 483, FDA expects written procedures for conducting a recall on distributed products up to and including specific instructions on how customers will be identified and notified.
Read more curated 483-observations in the GMP Trends Twice-Monthly Report.
