Drug factory · FDA FEI 3007182567

FUJIFILM Diosynth Biotechnologies UK Ltd

Belasis Avenue, Billingham, United Kingdom

Problems found, fixed voluntarily at FDA's last inspection, Mar 17, 2023.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2009: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Ecallantide	Makes the active ingredient	Takeda Pharmaceuticals America, Inc.	47783-101
Pegfilgrastim	Makes the active ingredient and tests it	Fresenius Kabi USA, LLC, Northstar Rx LLC.	65219-371, 72603-402

Ended	Result	Program	Problems noted
Mar 17, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 25, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 16, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 11, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	5
Jun 20, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 9, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.
Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the quality of drug products.
Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: analysis; api manufacture.