It may be of interest to note that the preamble to the 1996 publication of part 820 on the Federal Register stated:
iii. Device History Record (§ 820.184)
One comment stated the requirement should be amended because it explicitly requires that dates and quantities for each batch be in the DHR, while only implying through the general requirement that the DHR must also contain the batch test data.
FDA agrees with the last comment and has added in § 820.184 ‘‘(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR’’ to explicitly state the requirement to avoid any confusion.
I take this to say that the FDA's initial intention in issuing § 820.184 (d) was merely to require the inclusion of batch test data
in the DHR. Any concession later granted by the manufacturer to a non-conforming product, and any associated reasoning, would not, IMO, count as data
and therefore would not be covered by this requirement.