- Internal cGMP Audits
- GLP Audits
- GCP Audits
- Contract Manufacturer Audits
- Quality Systems Evaluation
- Compliance Gap Assessments
- Mock FDA Audits
- Compounding Pharmacy Audits
- Pre Approval Inspection Support
- API ICH Q7A Audits
- Labeling/Packaging Audits
- Supplier Audits
- Surveillance Audits
- Validation Audits
- Design of Audit Programs
- Dietary Supplement Compliance Audits
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Contact GQA
- 1-303-459-2382
- 1-866-216-2815
- info@gqaconsulting.com
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Industry Definitions
FDA Form 483
A listing of observations of objectionable conditions and practices, pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, to assist firms in complying with the Acts and regulations enforced by the Food and Drug Administration. This listing is presented to the highest management official available upon completing an inspection and before leaving the premises.
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