Following inspections on 25 July 2023 and 8 April 2024, critical deficiencies were identified in relation to data integrity, good distribution practice, lack of protection from microbial and other contamination, and inadequate control of packaging changes. This Statement of Non Compliance does not include the manufacture of critical products. Such products should be agreed in writing with individual National Competent Authorities. Action taken/proposed by the NCA: Withdrawal of current valid GMP certificates: UK MIA 17907 INSP GMP 17907/13988-0035[H] Recall of batches: No recalls necessary at the time of issuance of this SONC. Prohibition of supply: Only batches of critical products can be supplied to UK markets while this statement of non-compliance remains in force.
Inspection Record
Bristol Laboratories Limited — MHRA GMP NCR Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
1Data integrity
About this record
Extracted automatically from the document UK MHRA published on 2024-05-23. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
