Preparing for FDA Functional Cosmetics (OTC) Manufacturing Facility Inspections?

FDA Functional Cosmetics (OTC) Manufacturing Facility Inspection Preparation, with Assistance from J&B

In the U.S., functional cosmetics are classified as OTC (over-the-counter) drugs and must be registered with the FDA for both facility and product.

OTC includes products like sunscreen, antiperspirants, dandruff shampoos, acne products, and skin protectants.

Companies exporting these products must prepare for FDA inspections. In many cases, registrations are canceled during inspections due to a lack of knowledge of the regulations.

The key areas of focus during an FDA inspection are as follows (for OTC functional cosmetics, regular cosmetics follow GMP regulations for cosmetics):

PART 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals

Subpart A - General Regulations

§ 211.1 - Scope.

§ 211.3 - Definitions.

Subpart B - Organization and Personnel

§ 211.22 - Responsibility of the Quality Control Unit.

§ 211.25 - Personnel qualifications.

§ 211.28 - Personnel responsibilities.

§ 211.34 - Consultants.

Subpart C - Buildings and Facilities

§ 211.42 - Design and construction features.

§ 211.44 - Lighting.

§ 211.46 - Ventilation, air filtration, air heating, and cooling.

§ 211.48 - Plumbing.

§ 211.50 - Sewage and waste disposal.

§ 211.52 - Sanitation facilities.

§ 211.56 - Hygiene.

§ 211.58 - Maintenance.

Subpart D - Equipment

§ 211.63 - Equipment design, size, and location.

§ 211.65 - Equipment construction.

§ 211.67 - Equipment cleaning and maintenance.

§ 211.68 - Automation, machinery, and electronic equipment.

§ 211.72 - Filters.

Subpart E - Control of Components and Drug Containers and Closures

§ 211.80 - General requirements.

§ 211.82 - Receipt and storage of untested components, drug containers, and closures.

§ 211.84 - Testing and approval or rejection of components, drug containers, and closures.

§ 211.86 - Use of approved components, drug containers, and closures.

§ 211.87 - Re-examination of approved components, drug containers, and closures.

§ 211.89 - Rejected components, drug containers, and closures.

§ 211.94 - Drug containers and closures.

Subpart F - Production and Process Controls

§ 211.100 - Written procedures; deviations.

§ 211.101 - Introduction of components.

§ 211.103 - Yield calculations.

§ 211.105 - Equipment identification.

§ 211.110 - In-process material and drug sampling and testing.

§ 211.111 - Time limitations on production.

§ 211.113 - Control of microbial contamination.

§ 211.115 - Reprocessing.

Subpart G - Packaging and Labeling Control

§ 211.122 - Inspection and use of materials.

§ 211.125 - Label issuance.

§ 211.130 - Packaging and labeling operations.

§ 211.132 - Tamper-evident packaging requirements for human OTC drugs.

§ 211.134 - Drug inspections.

§ 211.137 - Expiration date labeling.

Subpart H - Storage and Distribution

§ 211.142 - Warehouse procedures.

§ 211.150 - Distribution procedures.

Subpart I - Laboratory Controls

§ 211.160 - General requirements.

§ 211.165 - Testing and release for distribution.

§ 211.166 - Stability testing.

§ 211.167 - Special testing requirements.

§ 211.170 - Retained samples.

§ 211.173 - Laboratory animals.

§ 211.176 - Penicillin contamination.

Subpart J - Records and Reports

§ 211.180 - General requirements.

§ 211.182 - Equipment cleaning and use records.

§ 211.184 - Records for components, drug containers, closures, and labeling.

§ 211.186 - Primary production and control records.

§ 211.188 - Batch production and control records.

§ 211.192 - Review of production records.

§ 211.194 - Laboratory records.

§ 211.196 - Distribution records.

§ 211.198 - Complaint files.

Subpart K - Returned and Recalled Drugs

§ 211.204 - Returned drugs.

§ 211.208 - Drug recalls.

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jay@jnbfoodconsulting.com or 714-873-5566