Inspection of a testing facility. (a) A testing facility shall permit an authorized employee or duly des- ignated representative of EPA or FDA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens re- quired to be maintained regarding studies to which this part applies. The records inspection and copying require- ments shall not apply to quality assur- ance unit records of findings and prob- lems, or to actions recommended and taken, except the EPA may seek pro- duction of these records in litigation or formal adjudicatory hearings.
Inspection of a testing facility. ( a) A t es t i n g fa xxxx x x x x x ll pe r m i t a n a u t h o r ized e m plo y ee o r d u l y des- ig n a t ed r ep r ese n t a t ive of E P A o r F DA, a t r e a so n a ble x x x es a n d i n a r e a so n a ble m a nn e r , t o i n spec t t h e fa cili t y a n d t o i n spec t ( a n d i n t h e c a se of r eco r ds a l so t o cop y) a ll r eco r ds a n d speci m e n s r e- q u i r ed t o be m a i n t a i n ed r eg a r di n g s t u dies t o w h ic h t h i s p a r t a pplies. T h e r eco r ds i n spec t io n a n d cop y i n g r eq u i r e- m e n t s s h a ll n o t a ppl y t o q u a li t y a ss ur- a n ce un i t r eco r ds of fi n di n gs a n d p r ob- le m s, o r t o a c t io n s r eco mm e n ded a n d t a k e n , excep t t h e E P A m a y see k p r o- d u c t io n of t h ese r eco r ds i n li t ig a t io n o r fo r m a l a dj u dic a t o xx x x x x x x gs.
