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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 820 - PART 820—QUALITY SYSTEM REGULATION
Subpart A [§ 820.1 - § 820.5] - Subpart A—General Provisions
Subpart B [§ 820.20 - § 820.25] - Subpart B—Quality System Requirements
Subpart C [§ 820.30 - § 820.30] - Subpart C—Design Controls
Subpart D [§ 820.40 - § 820.40] - Subpart D—Document Controls
Subpart E [§ 820.50 - § 820.50] - Subpart E—Purchasing Controls
Subpart F [§ 820.60 - § 820.65] - Subpart F—Identification and Traceability
Subpart G [§ 820.70 - § 820.75] - Subpart G—Production and Process Controls
Subpart H [§ 820.80 - § 820.86] - Subpart H—Acceptance Activities
Subpart I [§ 820.90 - § 820.90] - Subpart I—Nonconforming Product
Subpart J [§ 820.100 - § 820.100] - Subpart J—Corrective and Preventive Action
Subpart K [§ 820.120 - § 820.130] - Subpart K—Labeling and Packaging Control
Subpart L [§ 820.140 - § 820.170] - Subpart L—Handling, Storage, Distribution, and Installation
Subpart M [§ 820.180 - § 820.198] - Subpart M—Records
Subpart N [§ 820.200 - § 820.200] - Subpart N—Servicing
Subpart O [§ 820.250 - § 820.250] - Subpart O—Statistical Techniques
authority:
21 U.S.C. 351
,
352
,
360
,
360
c,
360
d,
360
e,
360
h,
360
i,
360
j,
360
l,
371
,
374
,
381
,
383
;
42 U.S.C. 216
,
262
,
263a
,
264
source:
61 FR 52654, Oct. 7, 1996, unless otherwise noted.
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