Warning Letter January 20, 2011
Baxter Healthcare Puerto Rico
1. The Jayuya Facility (Puerto Rico)
A. CGMP Violations
1. Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. § 211.192].
For example, investigations, (b)(4) and (b)(4) identified an equipment malfunction as the root cause of discolored product. These investigations did not address the possibility of carryover of solution due to the equipment malfunction. Additionally, the investigations did not extend to other lots manufactured on the non-dedicated filling line. Subsequently, your firm released 17 lots of product that were at risk of cross contamination to the market.
Comment
When a facility investigates issues to include equipment malfunctions, other lots involved, regardless of whether the filling line is dedicated or not, should be examined. Thinking in terms of “silosâ€, e.g., a single lot is not a good practice and one where the FDA especially takes note. Products released, in-process, on hold, or in quarantine should be reviewed to determine if the issue, in this case an equipment malfunction to determine discolored product, is extended to other lots either completed or in various states of manufacturing.
Furthermore, your firm failed to thoroughly investigate and correlate consumer complaints for discolored drug product distributed by your firm. On September 7, 2010, your firm initiated a recall of 17 lots of drug product associated with the equipment failure but only after our inspection identified deficiencies in your investigation and management of consumer complaints. Your firm identified the root cause of the discoloration that occurred on October 30, 2009, approximately one year prior to initiating a recall.
Comment
The FDA should not become your Quality Control Unit. When the FDA identifies deficiencies in facilities’ investigation and management of consumer complaints, the QCU needs to determine how it can improve. In addition, the recall occurred a year following the firm’s identification of the root cause – which suggests indecision within the organization.
Lastly, your investigation concluded that the administering health care professionals (i.e., pharmacist, nurse, or physician) would identify any discoloration and prevent the usage of the drug product. It is unacceptable to rely upon the health care professional to fulfill your Quality Control Unit responsibilities.
This is a repeat observation from the March 2008 inspection.
Comment
To not recall a product based on an investigation that concludes the health care professional “would identify any discoloration and prevent the usage of the drug product†is an unacceptable practice. The Quality Control Unit should have an Acceptable Quality Level that reflects adequate specifications. Health Care Professionals should be receiving product “fit for use†(Juran/Demming) and not that just meet specifications.
The FDA takes a very dim view of repeat observations. When promises are made during audits, within responses to FDA 483s, or following Warning Letters, the lack of Corrective Active will often lead to additional Warning Letters or more severe official actions on the part of the Agency.
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