Hospira receives FDA warning letter

Mike Verespej

Published: August 31, 2012 6:00 am ET

Related to this story

Topics Medical

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.”


Comments

Hospira receives FDA warning letter

Mike Verespej

Published: August 31, 2012 6:00 am ET

Post Your Comments


Back to story


More stories

Image

Pyramid investing in new presses as it targets sales in medical, technical molding

January 21, 2015 1:40 pm ET

Custom molder Pyramid Plastics Inc. is investing to boost its stake in medical and technical molding.    More

Image

Roechling buys HPT to expand presence in pharmaceutical packaging

January 13, 2015 4:55 pm ET

Global plastics processor Roechling Engineering Plastics KG is beefing up its presence in pharmaceutical packaging by acquiring German molder HPT...    More

Market Reports

Plastics in Automotive: Innovation & Emerging Trends

This special report newly released by PN and sponsored by The Conair Group examines current trends in the use of plastics in automotive, materials innovations and the changing landscape. It includes a review of legislative/regulatory activity impacting vehicle development and lightweighting, market opportunities & challenges for mold and toolmakers, innovative design strategies being implemented by major OEMs and suppliers, as well as a review of key indicators in Canada, Mexico, Brazil and China.

Learn more

Plastics Recycling Trends in North America

This report is a review and analysis of the North American Plastics Recycling Industry, including key trends and statistics based on 2013 performance. We examine market environment factors, regulatory issues, industry challenges, key drivers and emerging trends in post-consumer and post-industrial recycling.

Learn more

Injection Molding Market Analysis & Processor Rankings

Plastics News BUNDLED package contains our in-depth Market Analysis of the Injection Molding segment. You will gain keen insight on current trends and our economic outlook.

As a BONUS this includes PN's updated 2014 database of North American Injection Molders RANKED by sales volume. Sort, merge, mail & prospect by end market, materials processed, region, # of plants and more.

Learn more

Upcoming Plastics News Events

February 4, 2015 - February 6, 2015Plastics News Executive Forum 2015

June 2, 2015 - June 3, 2015Plastics Financial Summit - Chicago 2015

September 16, 2015 - September 18, 2015Plastics Caps & Closures - September 2015

More Events