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483
•Kendal Nutricare Ltd.•June 21, 2024

Kendal Nutricare Ltd. – FDA 483, Jun 21, 2024

Record Details

Kendal Nutricare Ltd., an infant formula manufacturer in Kendal, United Kingdom, was cited for significant deficiencies during an FDA inspection. Observations included inadequate process controls for microbial contamination, unsanitary facility conditions, insufficient testing of raw materials, and improper temperature monitoring in thermal processing. These issues indicate a lack of control over critical manufacturing processes and facility maintenance, posing potential risks to product quality and safety.

Company
Kendal Nutricare Ltd.
Inspection date
June 21, 2024
Product type
other
Office
Office of Biological Products Operations - Division I
People
  • Elizabeth P. Mayer
  • Daniel Gajevski
  • Todd Cadre
  • Gale L. Glinecki (Investigator )
View Company Profile

ID · c0e7b6fc-1ec8-47c3-bf2e-184016db2028

Other documents for Kendal Nutricare Ltd.
  • EIR - 2024-06-21June 21, 2024
  • EIR - 2023-06-23June 23, 2023

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