LAKE FOREST, ILL. (Aug. 31, 2:05 p.m. ET) — Pharmaceutical and medical device company Hospira Inc. has received a warning letter from the Food and Drug Administration because the audible alarms on some of the infusion pumps made at its plant in La Aurora de Heredia, Costa Rica, are still experiencing problems despite manufacturing changes made to the pumps after their initial recall 18 months ago.
The warning letter — received Aug. 22 and acknowledged in an Aug. 28 filing that the Lake Forest, Ill., company made with the Securities and Exchange Commission — said that the infusion pumps and intravascular administrative sets made at the plant do not conform with the agency's current “good manufacturing practice requirements.”
Some of the violations cited by the FDA were:
• Failure to take the necessary steps to prevent that audible alarm problem for recurring,
• Failure to identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems,
• Failure to implement and record changes in methods and procedures needed to correct and prevent identified quality problems,
• Failure to establish adequate procedures for acceptance of incoming products,
• Failure to keep adequate records of the devices it makes,
• Failure to evaluate suppliers, contractors, and consultants on the basis of their ability to meet specified requirements,
• Failure to maintain device record histories.
The Costa Rica plant in question makes infusion pumps and intravascular administrative sets sold under the names Symbiq, Plum, Gemstar, and Lifecare PCA. The warning letter does not restrict any production or shipping from the plant.
The warning letter came after FDA felt Hospira had not properly addressed issues that the FDA brought to the company's attention after a four-day inspection of the plant in mid-April.
Hospira has 15 business days from the receipt of the letter—-or until Sept. 13—to apprise FDA, in writing, of the specific steps it has taken to correct the noted violations and to explain how it plans to prevent these violations, or similar violations, from occurring again.
“The company takes this matter seriously and intends to respond fully, and in a timely manner, to the FDA's warning letter,” said Hospira in its SEC filing.
The focal point of the FDA investigation is a Plum-branded infusion pump made at the plant that was subject to a product recall in February 2011 because of problems with the audio alarm.
“The original piezo alarm ... was redesigned with new specifications to correct defective components on the piezoelectric assembly and provided a new part number effective November 11, 2011,” said the letter. “[But] in March of 2012, your firm received multiple complaints of no audible alarms on Plum devices after the supplier corrective action was initiated.”
“The corrective action was to implement changes to the printed circuit board and piezo alarm and have the supplier ... perform Highly Accelerated Stress Surveillance (HASS) testing,” said the FDA letter. “Since implementation of the corrective actions, 50 lots of the redesigned piezo alarm were received by your firm. However, there was no documented inspection or testing of this critical component. Additionally, Hospira did not have any records of HASS testing results.”
In addition, the FDA letter noted that Hospira further initiated a separate recall last September on Plum-branded infusion pumps “to correct an unrestricted free-flow condition.”
“An investigation was conducted and corrective actions were implemented by Hospira to ensure that proper installation of the regulator closure (source of the failure) was completed during manufacturing,” said the FDA letter. “During review of the regulator closure installation [during the FDA inspection in April], the investigator noted an obsolete instruction in ... mechanism assembly i nstructions ... to insert the regulator closer with a flat-head screw driver [when] the correct action ... calls for the regulator closer to be installed using a force gauge with an applied force of 20-25 pounds.”
In addition, those instructions, said the FDA, call for “a visual inspection after installation of the regulator closure.
“During the observation of the regulator closure installation, the investigator noted that the visual inspection did not occur,” said the warning letter. “Your firm did not provide documented evidence that the visual inspection is being performed in the manufacturing process.”