| This week: 1 EU GMP non-compliance report · 4 MHRA alerts · 11 Health Canada recalls · 2 new final FDA guidances. |
The signal |
| FDA FINAL GUIDANCE |
| Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry |
Blood, Blood Products · Oct 14, 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 111.100 |
| A dietary-supplement manufacturer did not establish, maintain, and follow the written procedures required for its manufacturing operations, so the production and process controls were not defined and consistently applied. |
| The recurring root cause: Required manufacturing SOPs never established, so operations run on undocumented practice. |
| 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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