...records shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records. (June 25, 1938, ch. 675, § 704, 52 Stat. 1057; 1940 Reorg. Plan No. IV. § 12, eff....

...medical device reports filed during the preceding year, or that no reports were filed. These reports enable FDA to protect the public health by helping...authorized FDA employee at all reasonable times to have 21 CFR Ch. I (4-1-99 Edition} access to, and to copy and verify, the records contained in this file....

...cause or contribute to a death or serious injury if the malfunction were to recur. These reports will enable FDA to protect the public health by helping...and effective for their intended use. In addition, a device importer is required to establish and maintain a complaint file and to permit any authorized...

...location as the manufacturer maintains its complaint file under §§820.180 and 820.198. An importer shall permit any authorized FDA employee at all reasonable...to and to copy and verify the records contained in the complaint file. (d) A manufacturer shall retain copies of records of any information, including...

...as the manufacturer maintains its complaint file under §§ 820.180 and 820.198. An importer shall permit any authorized FDA employee at all reasonable...to and to copy and verify the records contained in the complaint file. (d) A manufacturer shall retain copies of records of any information, including...

...its complaint file under § 820.198 the records referred to in this paragraph. The manufacturer shall permit any authorized FDA employee at all reasonable...have access to and to copy and verify the records referred to in this paragraph. (Approved by the Office of Management and Budget under control no. 0910-0201)...

...cause or contribute to a death or serious injury if the malfunction were to recur. These reports will enable FDA to protect the public health by helping to ensure that devices are not adulterated or mlsbranded and are otherwise safe and effective for their Intended use. In addition, a device importer...

...are also required to report certain device malfunctions. These reports will assist FDA in protecting the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. (b) This part supplements and does not supersede other provisions...

...health evaluation of each manufactured batch of infant formula and shall permit any authorized PDA employee at all reasonable times to have access to and to copy and verify the records referred to In this paragraph. (4) To retain the exempt status of an infant formula covered by this...

...files maintained under §211.198 of this chapter. (3) Manufacturers, packers, and distributors shall permit any authorized FDA employee, at all reasonable times, to have access to and copy and verify the records established and maintained under this section. (g) Disclaimer. A report...