Regulatory Focus™ > News Articles > Warning Letter Analysis: Supplement Manufacturers Cited for CGMP Violations, Lawncare

Warning Letter Analysis: Supplement Manufacturers Cited for CGMP Violations, Lawncare

Posted 12 June 2012 | By

The US Food and Drug Administration (FDA) is continuing to crack down on dietary supplement manufacturers for alleged current good manufacturing practices (CGMP) violations, sending out two more warning letters to northeast supplement manufacturers NatureMost and Himalayan Institute of Buffalo. Among this batch of warning letters' most prominent warnings: swapping ingredients without warning, violative marketing claims and a failure to cut the grass.

NatureMost of New England, Inc. (Dietary Supplement)

A three-week inspection of NatureMost's Middletown, CT manufacturing facility by FDA found alleged deficiencies in the company's regulatory adherence to CGMPs, causing the products manufactured at the facility to be deemed adulterated under the Federal Food, Drug and Cosmetic Act (FD&C Act).  Further inspection by FDA found two products marketed by NatureMost to be using claims reserved for medicinal products, causing them to violate the FD&C Act.

FDA's letter goes on to detail eight purported deficiencies found at the Middletown manufacturing facility, including:

  • failure to test all components to ensure the correct identity of manufacturing ingredients
  • failed to establish component specifications for identity, strength, purity and composition
  • failure to verify the integrity of the entire manufacturing process through thorough batch testing
  • failed to keep complete records of the batch production process
  • failed to follow written established procedures for inspecting the condition of containers prepared for shipment
  • failure to keep batch records for numerous products
  • failed to establish and maintain written master manufacturing records for each unique formulation for dietary supplement manufactured at the facility
  • failed to establish safeguards to prevent contaminants from entering into the product manufacturing process

In addition to the above warnings and its admonition of the company for marketing products with medicinal claims, FDA said the company failed to keep its facilities in good order. Specifically, the surrounding grounds of the facility were overrun with weeds and four-foot-long grass, which can attract pets to the facility and introduce unnecessary contaminants.

Himalayan Int'l Inst. of Yoga Science and Phil. (Dietary Supplement)

In its 24 May letter to the Himalayan Institute of Buffalo, FDA issued a lengthy list of alleged deficiencies ranging from violating acceptable CGMP practices, the proliferation of violative marketing claims on numerous products and the replacement of supplement ingredients with other ingredients without changing the labeling.

Like NatureMost, the bulk of FDA's warning letter to the Himalayan Institute focused on alleged CGMP deficiencies. Purported failures included:

  • failure to maintain written master manufacturing records
  • failure to maintain the proper identify of the product per the label
  • failure to test manufacturing materials for accuracy of identity
  • failure to establish manufacturing specifications
  • failure to quarantine components before manufacture
  • failure to include information about the characteristics of a package on the product labeling
  • failure to include batch production record information on the product
  • failure to establish written procedures for quality control procedures
  • failure to keep written procedures for lab operations
  • failure to establish procedures to review and investigate product complaints
  • failure to establish procedures to handle products returned to the company
  • failure to calibrate of inspect equipment on a routine basis
  • failure to maintain records of equipment inspections

FDA said it has additional concerns related to the facility's training of personnel, the lack of a defined quality control team and instances in which ingredients were swapped without updating the package label, and called for a written response within fifteen days of the receipt of the warning letter.

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