Problems at Hospira's Rocky Mount Facility Continue as FDA Issues Second Warning Letter
Life sciences manufacturer Hospira is once again the subject of a Warning Letter from the US Food and Drug Administration (FDA) alleging deficiencies at a long-troubled North Carolina manufacturing facility.
Background
Hospira has been the subject of five prior warning letters since August 2009, all of which related to current good manufacturing practice (CGMP) deficiencies at various plants and locations.
| Company | Date of WL | Location | Subject of Warning Letter |
|---|---|---|---|
| Hospira Inc | 08/12/2009 | Morgan Hill, CA | CGMP/QSR/Medical Devices/Adulterated |
| Hospira, Inc. | 04/12/2010 | Rocky Mount, NC | CGMP for Finished Pharmaceuticals/Deviations/Adulterated |
| Hospira Costa Rica Ltd. | 08/22/2012 | La Aurora de Heredia, Costa Rica | CGMP/QSR/Medical Devices/Adulterated |
| Hospira Inc. | 05/09/2013 | Lake Forest, IL | CGMP/QSR/Medical Devices/Adulterated |
| Hospira Healthcare India Pvt. Ltd. | 05/28/2013 | Irungattukottai, India | CGMP/Adulterated |
And adding to its troubles, Hospira has also issued a torrent of recalls in recent years, including:
- An August 2013 recall of Aminosyn because of an "unknown foreign particle" in the product.
- A September 2013 recall of Lidocaine HCl Injection due to "visible particulate" later determined to be oxidized stainless steel.
- A September 2013 recall of Bupivacaine HCl Injection due to "Presence of Particulate Matter"
- A March 2013 recall of sodium chloride injection due to "small gray/brown particles" later determined to be a combination of copper, zinc and lead.
- A February 2013 recall of injectable propofol products due to other visible particulate contamination.
Lead-Up to an Inspection
It was around the time of these recalls that FDA made a return visit to Hospira's Rocky Mount, NC manufacturing facility, which had received a Warning Letter in 2010 but had never received a close-out letter from FDA indicating that conditions had improved to acceptable levels. In March 2013, FDA issued the plant a Form 483, used to indicate deficiencies, after a re-inspection.
According to Outsourcing Pharma, the facility has been undergoing remediation challenges since then, but was hoping to alleviate those challenges in 2014 and emerge from an FDA inspection with a close-out letter. And as of February 2014, company officials said they were confident that its hundreds of millions in upgrades to the plant put it on track for a successful re-inspection.
Warning Letter Issued
Those hopes appear to have been dashed today, as FDA issued the company another Warning Letter following a September/November 2013 inspection of the Rocky Mount facility.
The 7 March 2014 Warning Letter, while not as extensive as the prior 2010 letter, highlighted five issues for immediate correction, all of which are related to recordkeeping and documentation.
For example, FDA alleges in its letter that Hospira failed to properly evaluate and review complaints involving product failures in accordance with 21 CFR 820.198(c). FDA said records it consulted found at least one unit which failed leak testing prior to distribution.
"Although the unit failed the air leak testing, the test conclusion qualified the confirmed air leaks as unrepresentative and the lot was subsequently deemed acceptable for release," FDA wrote. "At least one malfunction has occurred in the field for this lot."
While Hospira has worked to address this complaint, FDA said it requires additional data for it to be resolved.
Other Problems
A second FDA complaint centers around an alleged lack of documentation of monitoring and control methods, per 21 CFR 820.75(b)(2). Specifically, FDA said Hospira did not have controls in place to monitor the bioburden of devices used in one of its sterilization processes. As with the first issue, FDA said it sought additional data from Hospira to be able to adequately evaluate the company's response.
In other cases highlighted by FDA, Hospira failed to properly investigate complaints, including evaluating the full extent of manufacturing problems. In one instance, Hospira allegedly failed to review a lot of one of its products for particulate contamination despite it having been manufactured from the same parent lot of product that resulted in the recall of another product in 2013. In other instances, FDA said it was unable to determine if corrective and preventive action (CAPA) had been taken to prevent future nonconformities from occurring.
The letter goes on to indicate that failure to take "prompt action to correct the violations addressed in [the] letter" may result in escalating regulatory actions, up to and including seizures, injunctions and civil money penalties.