FDA 483 OBSERVATION · #152 OF 1,923 MOST-CITED
Procedures for non-sterile drug products
FDA cited this observation 202 times across 187 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
Written procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are lacking or inadequate, as required by §211.113(a) — the microbial control expected for non-sterile dosage forms such as oral liquids, topicals, and solids.
Why FDA writes it — Non-sterile does not mean uncontrolled. FDA protects against non-sterile products carrying objectionable organisms — pathogens or high bioburden that can harm patients or spoil the product — because the firm never defined the controls, limits, or testing that keep microbial quality in check.
- Establish written procedures preventing objectionable microorganisms, including water quality, cleaning, bioburden, and preservative controls.
- Define microbial specifications and objectionable-organism criteria appropriate to the dosage form and route of administration.
- Monitor microbial quality of components, water, and finished product against those limits, with defined action on excursions.
- Validate preservative effectiveness where applicable and control conditions that support microbial growth.
- The firm assumes non-sterile products need no microbial program and defines no objectionable-organism criteria.
- Water systems and cleaning are not controlled to a microbial limit, allowing bioburden to enter the product.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 5.4× the rate of the average FDA-cited firm (41.7% vs 7.8%), across 187 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →