Whole Foods Receives Warning from FDA for Numerous Violations at Manufacturing Facility

June 21, 2016

On Wednesday, June 8th, the FDA issued a warning letter to Whole Foods Markets Inc., citing the company’s Everett, Massachusetts manufacturing facility for several GMP violations.  The violations involved FDA’s regulations for manufacturing, packing, or holding human food.  In the warning letter, FDA stated that the violations cause the food products being manufactured at the facility to be “adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.”

Following the inspection, Whole Foods received a Form FDA-483 on February 26, 2016, which outlined the serious violations that were observed by the Agency.  These violations include:

  • Failure to “manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2).”
  • Failure to “maintain equipment in an acceptable condition through appropriate cleaning and sanitizing as required by 21 CFR 110.80(b)(1).”
  • Failure to “sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned as required by 21 CFR 110.35(d)(1).”
  • Failure to “take proper precautions to protect food and food-contact surfaces from contamination with chemicals, filth and extraneous materials due to deficiencies in plant design as required by 21 CFR 110.20(b)(2).”
  • Failure to provide suitable hand-washing facilities; specifically, FDA noted that the facilities “lack running water of a suitable temperature as required by 21 CFR 110.37(e).”
  • Failure to “properly identify toxic sanitizing agents in a manner that protects against contamination of food as required by 21 CFR 110.35(b)(2).”

On March 17, 2016, Whole Foods reacted to the observations and submitted a written response to the FDA.  The warning letter states the company’s response indicated that Whole Foods takes the observations seriously and is committed to correcting the deficiencies.  However, the FDA is still concerned that the company’s facility was operating under such conditions to begin with.  Furthermore, the Agency notes that Whole Foods’ response “includes retraining of employees as a corrective action for most of the observed violations,” but the company “failed to mention adequate supervision over your specialized food processing operations and how retraining will ensure sustained compliance.”

In the warning letter, FDA states that it does not consider Whole Foods’ response to be acceptable because the company did not provide documentation for the Agency to review, demonstrating that all corrective actions have been effectively implemented.  “This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections.”

Whole Foods must respond to the warning letter within 15 days, listing the specific things that the company is doing to correct the violations.  In addition, FDA states that the response “should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.”  If corrective action cannot be completed within 15 working days, Whole Foods must provide the reason for the delay and the time frame in which the corrections will be completed.

Have you received a Form 483 or warning letter from the FDA?  Have you been issued a Consent Decree from the FDA? Are you seeking to avoid FDA action and looking to ensure GMP compliance? We can help with all of your quality and compliance needs.  For more information on our services and how we can help you, contact us today.


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