A recently released FDA Warning Letter portrays a tighter interpretation of 21 CFR part 820.50, in so much as they expect to be able to review documented record for items a) to d) below. It must also be understood that other branches of the FDA (Drugs & Bio) have ascertained that when 21 CFR 211 lacks detail; they will audit to detail in 21 CFR 820 (if any).
Although the wording used in a) & b) would definitely identify them as applicable to medical devices parts; c) & d) are not. Also the fact that they mention in b) & c); that these requirements are applicable to - contractors and services rendered. This for many companies will be very disconcerting.
Extract from warning letter:
a) Your firm has not documented the evaluation and approval of suppliers of components used in the manufacture or assembly of the xxxxx xxx xxxx measurement device.
b) Your firm does not have a documented agreement with any component suppliers or contractors to notify it of changes made in the components supplied or services rendered.
c) Your firm has not established the requirements that must be met by suppliers and contractors.
d) Your firm does not maintain an approved suppliers list.
Precise extraction from WL CMS Case #175552
Alex Kennedy