Baxter International Inc. (BAX) has received a Food and Drug Administration warning letter relating to two Puerto Rico facilities where it makes nutrition and critical-care products, plus an anesthesia agent, the company disclosed Thursday.
The warning letter covers violations of good manufacturing practices at one facility and the failure to submit post-marketing reports at another. The letter mainly pertains to how Baxter investigates issues and reports matters to the FDA, and didn't describe any patient issues, Baxter Chief Executive Robert L. Parkinson, Jr., said during the company's fourth-quarter earnings call.
Baxter said it continues to manufacture the products at issue and said they remain safe and effective if used in accordance with labeled instructions. The company also said it made improvements during and immediately after the FDA inspections that led to the warning letter, and said it will further those efforts and present plans to the FDA in coming weeks.
The FDA issues warning letters when it finds problems at company facilities the agency believes need fixing. Such letters can sometimes prove time-consuming and costly to resolve. Also, the agency can choose to not approve any new products related to the products covered in the letter until the matter is resolved.
Baxter shares traded down 2.4% to $49.70 early Thursday. The company reported slightly better-than-expected adjusted earnings for the fourth quarter, but a guidance range for the new year that was mostly below the target among analysts surveyed by Thomson Reuters.
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