21 CFR 211.67 · 21 CFR 211.182
How to close an FDA 483
preventive maintenance finding
A § 211.67 observation is one of the most common findings on an FDA 483. Investigators issue it when equipment maintenance has been performed but the records cannot prove it. The corrective action is not to write a new procedure. It is to produce execution evidence that shows, step by step and timestamp by timestamp, that the procedure was actually followed.
This page shows exactly what that evidence must contain and what a compliant record looks like.
What the regulation requires
§ 211.67(b)"Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product."
eCFR · § 211.67
§ 211.182"The persons performing... shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order."
eCFR · § 211.182
The word the FDA focuses on is followed. A written procedure on file is necessary but it is not sufficient. The regulation requires a contemporaneous record that proves the procedure was executed, step by step, by a named person, at a specific time. Three things must be present in that record:
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Attribution by name and ID
Every step must identify who performed it. A single supervisor co-sign at the end does not satisfy § 211.67(b)(1). The individual who performed each task must be identified on the record.
§ 211.67(b)(1) - +
Step-level timestamps in sequence
§ 211.182 requires chronological order. That means timestamps captured at execution for each step, not a single completion time at the end of the shift or reconstructed from memory.
§ 211.182 - +
Signed and dated at close
The technician must date and sign the record at the moment the work is completed. A signature added later, or a batch sign-off at end of week, does not constitute a contemporaneous record.
§ 211.182
Why most PM records do not hold up
Most preventive maintenance programs have documented procedures, scheduled tasks, and a record of completion. What they are missing is execution evidence at the step level. A paper checklist signed at the end of a task does not prove when each step was performed or whether it was performed in sequence. A spreadsheet entry made hours after the work is done is not a contemporaneous record.
When an investigator issues a § 211.67 observation, they are not saying your maintenance did not happen. They are saying your record cannot prove it happened in the way your procedure requires. That distinction is why the corrective action cannot simply be a new SOP. It requires a new class of record.
Batch sign-off
Technician signs all tasks at end of shift. No way to verify sequence or timing of individual steps.
Paper checklist
Completion confirmed but no timestamp per step, no lot references, no individual attribution at step level.
Reconstructed entries
Log filled in from memory after the fact. Timestamps cluster suspiciously at round hours.
What compliant execution evidence looks like
A .pruved bundle captures every step at the moment it is performed.
Attribution, timestamp, and signature are embedded in the record as it is created. The bundle is sealed when the technician closes the task. Nothing can be changed after sealing. The export is the exhibit you submit in your corrective action response.
§ 211.67(a)
Equipment identified
HVAC-UNIT-07 · EQ-2024-0442
§ 211.67(b)(1)
Attributable
Technician · EMP-0318
§ 211.182
Chronological order
Step timestamps 09:14 to 09:28
§ 211.182
Date and sign at completion
Signed · bundle sealed
Closing the observation
Your CAPA response to a § 211.67 observation needs to demonstrate that the root cause has been addressed systemically, not just for the equipment named in the finding. A single corrected record is not enough. The FDA expects evidence that every covered piece of equipment will produce compliant records going forward.
A .pruved file is the exhibit. The sealed bundle export attaches directly to your corrective action as primary documentation. It satisfies § 211.67(b) and § 211.182 by construction. There is no gap between what the record contains and what the regulation requires, because the record was designed around those requirements.
The same record that closes this finding prevents the next one.
Your next inspection has a date
The evidence should already be there.
In 30 minutes we will map this to your equipment, show you the record your inspector will see, and walk through exactly how the export attaches to a corrective action response.
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