CBER Publishes 2017 Guidance Agenda
CBER released a set of guidance topics that the center is considering for development this year, covering blood and blood components, tissues and advanced therapies, and chemistry, manufacturing and controls…
Inadequate Written Procedures Land Warner Chilcott a Form 483
Drug manufacturer Warner Chilcott was handed a Form 483 after an inspection revealed inadequate written procedures and deficient cleaning and maintenance of equipment. Source: Drug Industry Daily
HHS Relaxes Proposed Common Rule Restrictions on Biospecimen Research
HHS backed down from implementing its more controversial provisions in a broad overhaul of its Common Rule, including requiring researchers to obtain written consent before testing a donor’s biospecimens, even…
Congress Receives FDA’s User Fee Reauthorization Recommendations
The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislation package due by…
Precision Interconnect Cited for Poor Documentation
Precision Interconnect was hit with a Form 483 for poor corrective and preventive action (CAPA) procedures and failing to ensure that products conformed to requirements. Source: The GMP Letter
Lack of Corrective Action Procedures Earn Hansen Ophthalmic Form 483
Hansen Ophthalmic Development Lab, Inc., received a Form 483 for not establishing procedures for corrective and preventive action, and for not maintaining a complete device history record. Source: The GMP…
Panoramic Corp. Gets Form 483 for Reporting Failures
Panoramic Corp. received a Form 483 for not reporting a correction and removal to the FDA and failing to submit medical device reports (MDRs). Source: The GMP Letter
Inservco Inc. Receives Form 483 Citing Procedures, Device History
Inservco Inc. received a Form 483 for not establishing a complaint handling procedure, failing to properly maintain device history records, and other violations. Source: The GMP Letter
- Go to the previous page
- 1
- …
- 581
- 582
- 583
- 584
- 585
- 586
- 587
- …
- 610
- Go to the next page