21 CFR 212.30: What requirements must my facilities and equipment meet?
Requires PET drug producers to maintain facilities that prevent mix-ups and contamination, and to use documented procedures keeping equipment clean, suitable, installed, maintained, and non-reactive, non-additive, and non-absorptive on product-contact surfaces.
Part 212, Current Good Manufacturing Practice for Positron Emission Tomography Drugs · Subpart D, Facilities and Equipment
How FDA words it
The opening lines investigators use most when they cite 212.30, from the 483s we hold.
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product…Most used
Recent 483s citing 212.30
- Cardinal Health 414, LLC · Jackson, MississippiYour facilities are not adequate to ensure the prevention of contamination of… Mar 18, 2026
- Form 483 · FEI 3011121261 · Cleveland, OhioYour facilities are not adequate to ensure the prevention of contamination of… Feb 17, 2026
- PETNET Solutions, Inc. · North Wales, PennsylvaniaYour facilities are not adequate to ensure the prevention of contamination of… Sep 2, 2025
- SOFIE Co. dba SOFIE · Totowa, New JerseyYour facilities are not adequate to ensure the prevention of contamination of… Aug 11, 2023
- KP Pharmaceutical Technology, Inc. · Bloomington, IndianaFeb 3, 2023
The regulation text
§ 212.30 What requirements must my facilities and equipment meet?.
(a)Facilities. You must provide adequate facilities to ensure the orderly handling of materials and equipment, the prevention of mix-ups, and the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.
(b)Equipment procedures. You must implement procedures to ensure that all equipment that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained, is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results. You must document your activities in accordance with these procedures.
(c)Equipment construction and maintenance. Equipment must be constructed and maintained so that surfaces that contact components, in-process materials, or PET drugs are not reactive, additive, or absorptive so as to alter the quality of PET drugs.
Questions
What does 21 CFR 212.30 require?
Requires PET drug producers to maintain facilities that prevent mix-ups and contamination, and to use documented procedures keeping equipment clean, suitable, installed, maintained, and non-reactive, non-additive, and non-absorptive on product-contact surfaces.
How do FDA investigators word a 212.30 observation?
The most common opening is: “Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product…”
Which sections are cited alongside 212.30?
In the same 483s, investigators most often also cite 212.50 (What production and process controls must I have?), 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 212.20 (What activities must I perform to ensure drug quality?).