Drug factory · FDA FEI 3003217321
Bray Group Limited
Regal Way, Faringdon, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Sep 30, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2017: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrate Ion and Silver Cation | Makes it | McKesson Medical-Surgical, PSS World Medical, Inc. | 68599-6302, 68599-6303, 68345-100 |
| Silver Cation | Makes it | Bray Group Limited | 65875-101 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 30, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 4, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 4, 2017 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - In-process materials specifications testing 21 CFR 211.110(b)
Examination and testing of samples is not done to assure that in-process materials conform to specifications. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established. - Expiration date location on labeling 21 CFR 211.137(d)
Drug product expiration dates do not appear on the labeling in the manner prescribed by regulations. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Theoretical yield statement including percentages 21 CFR 211.186(b)(7)
Master production and control records lack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education, training and experience required to perform their assigned functions. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: manufacture.