| This week: 4 EU GMP non-compliance reports · 4 MHRA alerts · 13 Health Canada recalls · 3 new final FDA guidances. |
The signal |
| FDA FINAL GUIDANCE |
| Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers |
Biosimilars · Oct 9, 2026 |
| Read the record on SPEQ |
Closing windows |
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The enforcement desk · FDA · EU · UK · Canada |
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Decoded |
| 21 CFR 117.40 |
| Equipment and utensils were not of appropriate design, size, or installation/location to be adequately cleanable and to be maintained in a way that prevents contamination of food. |
| The recurring root cause: Equipment placed where surfaces and surroundings cannot be reached for cleaning. |
| Read the full interpretation |
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Regulator facts above are reproduced from the issuing authority and link to the record on SPEQ.
Blocks marked SPEQ READ are SPEQ's interpretation, not a
regulator's instruction, and are not legal or regulatory advice.
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