Regulations for cosmetic and OTC contract manufacturers

The texts FDA holds a plant making cosmetics and OTC drugs to: drug cGMP (21 CFR 210 and 211), electronic records and signatures (Part 11), cosmetic and OTC labeling, the cosmetics chapter of the FD&C Act with MoCRA, the sunscreen monograph, the FDA guidance that explains them and the warning letters that enforce them. Each section shows which of the warning letters cite it and, where BatchGlow enforces it, how.

Most cited in the warning letters

Sections cited as a violation in at least two of the 6 FDA warning letters in this collection.

By the work of the plant

• BatchGlow enforces the section; its page says how.

Receiving, sampling and testing components

21 CFR 211.80 • General requirements
21 CFR 211.82 • Receipt and storage of untested components, drug product containers, and closures
21 CFR 211.84 • Testing and approval or rejection of components, drug product containers, and closures
21 CFR 211.86 • Use of approved components, drug product containers, and closures
21 CFR 211.87 • Retesting of approved components, drug product containers, and closures
21 CFR 211.89 • Rejected components, drug product containers, and closures
21 CFR 211.184 • Component, drug product container, closure, and labeling records
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Revision 1) •

Master and batch records, weighing and charge-in

21 CFR 211.100 • Written procedures; deviations
21 CFR 211.101 • Charge-in of components
21 CFR 211.103 • Calculation of yield
21 CFR 211.110 • Sampling and testing of in-process materials and drug products
21 CFR 211.111 • Time limitations on production
21 CFR 211.186 • Master production and control records
21 CFR 211.188 • Batch production and control records
21 CFR 211.68 • Automatic, mechanical, and electronic equipment

Packaging, labeling and line clearance

21 CFR 211.122 • Materials examination and usage criteria
21 CFR 211.125 • Labeling issuance
21 CFR 211.130 • Packaging and labeling operations
21 CFR 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products
21 CFR 211.134 Drug product inspection
21 CFR 211.137 • Expiration dating

Quality unit, release and investigations

21 CFR 211.22 • Responsibilities of quality control unit
21 CFR 211.25 • Personnel qualifications
21 CFR 211.165 • Testing and release for distribution
21 CFR 211.192 • Production record review
21 CFR 211.194 • Laboratory records
21 CFR 211.180 • General requirements
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (Revision 1) •

Laboratory controls, stability and reserve samples

21 CFR 211.160 • General requirements
21 CFR 211.166 Stability testing
21 CFR 211.170 • Reserve samples
21 CFR 211.194 • Laboratory records

Equipment, cleaning and calibration

21 CFR 211.63 • Equipment design, size, and location
21 CFR 211.67 • Equipment cleaning and maintenance
21 CFR 211.68 • Automatic, mechanical, and electronic equipment
21 CFR 211.105 • Equipment identification
21 CFR 211.182 • Equipment cleaning and use log

Electronic records, signatures and data integrity

21 CFR 11.10 • Controls for closed systems
21 CFR 11.50 • Signature manifestations
21 CFR 11.70 • Signature/record linking
21 CFR 11.100 • General requirements
21 CFR 11.200 • Electronic signature components and controls
21 CFR 11.300 • Controls for identification codes/passwords
Data Integrity and Compliance With Drug CGMP: Questions and Answers •

Reprocessing, returns, complaints and recalls

21 CFR 211.115 • Reprocessing
21 CFR 211.198 • Complaint files
21 CFR 211.204 Returned drug products
21 CFR 211.208 Drug product salvaging
21 CFR 211.150 Distribution procedures
21 U.S.C. 364a • Adverse events (MoCRA)
21 U.S.C. 364g Mandatory recall authority (MoCRA)

Contract manufacturing

21 CFR 211.22 • Responsibilities of quality control unit
Contract Manufacturing Arrangements for Drugs: Quality Agreements

Cosmetics under MoCRA

21 U.S.C. 364b • Good manufacturing practice (MoCRA)
21 U.S.C. 364c • Registration and product listing (MoCRA)
21 U.S.C. 364d Safety substantiation (MoCRA)
21 U.S.C. 364e • Labeling (MoCRA)
21 U.S.C. 364f Records (MoCRA)
21 U.S.C. 364h • Small businesses (MoCRA)
21 U.S.C. 364i Exemption for certain products and facilities (MoCRA)
Registration and Listing of Cosmetic Product Facilities and Products
Draft Guidance for Industry: Cosmetic Good Manufacturing Practices

Cosmetic labeling

21 CFR 701.3 • Designation of ingredients
21 CFR 701.13 • Declaration of net quantity of contents
21 CFR 720.8 • Confidentiality of statements
21 CFR 740.1 Establishment of warning statements
21 CFR 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been obtained
21 U.S.C. 362 • Misbranded cosmetics

OTC drug labeling and the sunscreen monograph

21 CFR 201.66 • Format and content requirements for over-the-counter (OTC) drug product labeling
21 CFR 201.17 • Drugs; location of expiration date
21 CFR 201.18 Drugs; significance of control numbers
21 CFR 201.62 • Declaration of net quantity of contents
OTC Monograph M020.10 Sunscreen active ingredients
OTC Monograph M020.50 • Labeling of sunscreen drug products

All documents

Regulations (21 CFR)

21 CFR Part 210 CGMP in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR Part 211 CGMP for Finished Pharmaceuticals
21 CFR Part 11 Electronic Records; Electronic Signatures
21 CFR Part 201 Labeling (drugs)
21 CFR Part 700 Cosmetics: General
21 CFR Part 701 Cosmetic Labeling
21 CFR Part 710 Voluntary Registration of Cosmetic Product Establishments
21 CFR Part 720 Voluntary Filing of Cosmetic Product Ingredient Composition Statements
21 CFR Part 740 Cosmetic Product Warning Statements

FD&C Act, chapter VI: cosmetics, with MoCRA (21 U.S.C.)

21 U.S.C. 361 FD&C Act § 601, Adulterated cosmetics
21 U.S.C. 362 FD&C Act § 602, Misbranded cosmetics
21 U.S.C. 363 FD&C Act § 603, Regulations making exemptions
21 U.S.C. 364 FD&C Act § 604, Definitions (MoCRA)
21 U.S.C. 364a FD&C Act § 605, Adverse events (MoCRA)
21 U.S.C. 364b FD&C Act § 606, Good manufacturing practice (MoCRA)
21 U.S.C. 364c FD&C Act § 607, Registration and product listing (MoCRA)
21 U.S.C. 364d FD&C Act § 608, Safety substantiation (MoCRA)
21 U.S.C. 364e FD&C Act § 609, Labeling (MoCRA)
21 U.S.C. 364f FD&C Act § 610, Records (MoCRA)
21 U.S.C. 364g FD&C Act § 611, Mandatory recall authority (MoCRA)
21 U.S.C. 364h FD&C Act § 612, Small businesses (MoCRA)
21 U.S.C. 364i FD&C Act § 613, Exemption for certain products and facilities (MoCRA)
21 U.S.C. 364j FD&C Act § 614, Preemption (MoCRA)

OTC monograph

OTC Monograph M020 Sunscreen Drug Products for OTC Human Use

FDA guidance

FDA warning letters to cosmetic and OTC manufacturers

Woodbine Products Company Inc. 27 Jul 2026
Active Cosmetics Manufacturing Inc. 22 Apr 2026
Purolea Cosmetics Lab 2 Apr 2026
CDL Services, Inc. dba Technichem 24 Nov 2025
Columbia Cosmetics Manufacturing Inc. 11 Sep 2025
Accra-Pac, Inc. dba Voyant Beauty 20 Apr 2023