Shanwei Honghui Daily Appliance, Shanwei, China, inspected from July 31 to August 3, 2017.
- A failure in cleaning, maintaining , sanitising and sterilising of equipment and utensils was determined
- Written procedures for production and process control were not followed and process features were not documented while running
- There was no performance of batch laboratory determinations or microbiology tests
- No testing of incoming APIs or excipients
- No batch production and control records could be provided as there was no batch record performed for each batch.
Delta Laboratories, Somersby, Australia, inspected from March 27 to 31, 2017
- Unexplained discrepancy or failure of a batch was not thoroughly investigated
- Written procedures for production and process control were not established
- Adequate written testing program was not followed or even in place
- The Quality Unit is not fully exercising its authority or responsibilities
- No adequate process validation studies available.
Yicheng Chemical Corporation, Changzhou, China, inspected from July 17 to 21, 2017
- Failure to manufacture, weigh and repackage drugs and APIs in separate facilities which results in an unacceptable high risk of API cross-contamination
- Failure of Quality Unit to review batch production records prior to distribution of an API batch
- Failure of complete traceability of API in commercial distribution.
Wuhan Chinese Moxibustion Technology, Wuhan, China, inspected from May 22 to 26, 2017.
- Lack of adequate Quality Control Unit
- No master production and control records were prepared
- No laboratory controls were established
- No adequate written procedures for production and process control in place
- A failure in cleaning, maintaining , sanitising and sterilising of equipment and utensils was determined.
Schrofner Cosmetics, Salzburg, Austria, inspected from July 17–19, 2017.
- Lack of adequate Quality Control Unit and no written procedures for process- and cleaning validation and other manufacturing operations
- No master production and control records were established
- Finished drug products were released without testing of identification and strength of the API.
FDA: Warning Letters recently posted, subject cGMP