Clement Clarke International Ltd. was cited for problems with its validation and acceptance procedures, supplier evaluations, and controls for nonconforming products.
According to a Form 483, inspectors who visited the company’s Harlow, UK, facility in October found that Clement had not conducted various processes used to manufacture its Class II Peak Flow Meters in contravention of the firm’s procedures.
Inspectors also reported that software used as part of production and in the company’s quality system had not been validated for its intended use according to an established protocol.
Clement also did not follow its inspection and sampling procedures for certain incoming goods, including components of its Peak Flow Meter. In particular, the firm did not document any inspections of these components.
The FDA also said Clement failed to document the evaluation and selection of suppliers on the proper forms or evaluate production errors during weekly meetings to see if an investigation was needed.
Read the Form 483 here: www.fdanews.com/12-22-16-Clement.pdf.